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Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study (PRoMPT BOLUS)

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ClinicalTrials.gov Identifier: NCT03340805
Recruitment Status : Completed
First Posted : November 14, 2017
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
University of Utah
University of Pennsylvania
University of California, Davis
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Shock, Septic
Interventions Drug: Lactated Ringer
Drug: Normal saline
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Hide Arm/Group Description

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Period Title: Overall Study
Started 24 26
Completed 24 [1] 26
Not Completed 0 0
[1]
1 subject withdrew early from study fluid administration but stayed in trial for outcome assessment
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS) Total
Hide Arm/Group Description

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Total of all reporting groups
Overall Number of Baseline Participants 24 26 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
<=18 years
24
 100.0%
26
 100.0%
50
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 24 participants 26 participants 50 participants
3.8
(2.0 to 10.4)
9.7
(2.6 to 16.3)
5.8
(2.1 to 12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Female
11
  45.8%
12
  46.2%
23
  46.0%
Male
13
  54.2%
14
  53.8%
27
  54.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 24 participants 26 participants 50 participants
Non-Hispanic White
11
  45.8%
11
  42.3%
22
  44.0%
Non-Hispanic Black
3
  12.5%
4
  15.4%
7
  14.0%
Hispanic
10
  41.7%
9
  34.6%
19
  38.0%
Asian
0
   0.0%
1
   3.8%
1
   2.0%
Unknown/Not Reported
0
   0.0%
1
   3.8%
1
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 26 participants 50 participants
24 26 50
Comorbid Conditions  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Cancer 4 5 9
Kidney disease 2 1 3
Neurologic dysfunction 7 5 12
Chronic ventilator dependence 6 5 11
Bone marrow or solid organ transplant 3 2 5
Sickle cell disease 0 2 2
Indwelling central venous catheter 6 4 10
Any comorbid condition 16 16 32
Site of Infection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Bacteremia 2 4 6
Pneumonia/lung infection 5 5 10
Abdominal infection 1 0 1
Urinary Tract Infection 4 3 7
CNS infection 2 3 5
Skin/soft tissue infection 2 3 5
Other 6 6 12
Unknown 3 4 7
Alternative diagnosis other than infection 1 1 2
1.Primary Outcome
Title Compliance With Study Fluid Administration in the Assigned Study Arm
Hide Description Proportion of total crystalloids administered as saline in each arm during the intervention phase
Time Frame up 48 hours after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Hide Arm/Group Description:

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Overall Number of Participants Analyzed 24 26
Median (Inter-Quartile Range)
Unit of Measure: Proportion of total crystalloids adminis
0
(0 to 0)
100
(100 to 100)
2.Secondary Outcome
Title Enrollment of Eligible Patients
Hide Description Proportion of eligible patients treated in the pediatric ED who are enrolled, randomized, and treated with study fluid
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Eligible Patients
Hide Arm/Group Description:
All patients age >6 mos to <18 years with clinician suspicion of septic shock who did not meet exclusion criteria
Overall Number of Participants Analyzed 59
Measure Type: Count of Participants
Unit of Measure: Participants
50
  84.7%
3.Secondary Outcome
Title Acceptability of Enrollment Using "Exception From Informed Consent"
Hide Description Proportion of eligible patients who meet criteria for EFIC who are enrolled, randomized, and treated with study fluid and do not withdraw prior to completion of the follow-up phase
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Enrolled Under Exception From Informed Consent
Hide Arm/Group Description:
Eligible subjects enrolled under "exception from informed consent" process
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
43
  97.7%
4.Other Pre-specified Outcome
Title Mortality
Hide Description Proportion of enrolled patients who do not survive
Time Frame up to 90 days following randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Hide Arm/Group Description:

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Overall Number of Participants Analyzed 24 26
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   3.8%
5.Other Pre-specified Outcome
Title Hospital-free Days
Hide Description The number of calendar days alive and out of the hospital between randomization (day 0) and day 27 with death prior hospital discharge defined as "zero" hospital-free days
Time Frame up to 28 days following randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Hide Arm/Group Description:

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Overall Number of Participants Analyzed 24 26
Median (Inter-Quartile Range)
Unit of Measure: days alive and free of hospitalization
23
(20 to 25)
25
(20 to 26)
6.Other Pre-specified Outcome
Title New Inpatient Dialysis
Hide Description Proportion treated with any replacement therapy that was not a continuation of pre-hospital chronic therapy
Time Frame Up to 90 days following randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Hide Arm/Group Description:

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Overall Number of Participants Analyzed 24 26
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Other Pre-specified Outcome
Title Hospital Length of Stay
Hide Description Measured as the number of calendar days between ED arrival and ED or hospital discharge (whichever occurs later)
Time Frame up to 90 days following randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Hide Arm/Group Description:

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Overall Number of Participants Analyzed 24 26
Median (Inter-Quartile Range)
Unit of Measure: days
5
(3 to 8)
3
(2 to 9)
8.Other Pre-specified Outcome
Title Adverse Events
Hide Description Hyperlactatemia, hyperkalemia, hypercalcemia, hypernatremia, hyponatremia, hyperchloremia, therapy for brain herniation
Time Frame up to four days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Hide Arm/Group Description:

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Overall Number of Participants Analyzed 24 26
Measure Type: Number
Unit of Measure: adverse events
7 18
9.Other Pre-specified Outcome
Title Adverse Events
Hide Description Venous thromboembolism
Time Frame up to seven days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Hide Arm/Group Description:

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

Overall Number of Participants Analyzed 24 26
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 7 days
Adverse Event Reporting Description Selective AEs recorded were: Death, Cardiac arrest, Arrhythmia requiring intervention, Vasoactive infusion, ECMO, Invasive mechanical ventilation, Non-invasive mechanical ventilation, Dialysis (not pre-existing), Liver dysfunction, Limb necrosis, Brain herniation, Seizure, Pulmonary embolus, Deep venous thrombosis, Central venous line clot requiring pharmacologic therapy, Bleeding, Hospital infection, Pressure ulcer, IV infiltrate (grade 3 or 4), Rash, and electrolyte abnormalities
 
Arm/Group Title Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Hide Arm/Group Description

Lactated Ringer's (LR) fluid will be administered to patients randomized to the experimental arm. LR will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Lactated Ringer: LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calender day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.

Normal saline: Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.

All-Cause Mortality
Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      1/26 (3.85%)    
Hide Serious Adverse Events
Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/24 (16.67%)      2/26 (7.69%)    
Cardiac disorders     
Shock  1 [1]  2/24 (8.33%)  2 2/26 (7.69%)  2
General disorders     
Death  1  0/24 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders     
Cerebral edema  1  1/24 (4.17%)  1 0/26 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1 [2]  3/24 (12.50%)  3 1/26 (3.85%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
[1]
Requiring vasoactive medications
[2]
Requiring invasive ventilation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lactated Ringer's Fluid (LR) 0.9% "Normal" Saline Fluid (NS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/24 (45.83%)      12/26 (46.15%)    
Hepatobiliary disorders     
Liver dysfunction  1  0/24 (0.00%)  0 1/26 (3.85%)  1
Metabolism and nutrition disorders     
Hyperlactatemia  1 [1]  2/24 (8.33%)  2 4/26 (15.38%)  4
Hyperkalemia  1 [2]  2/24 (8.33%)  2 2/26 (7.69%)  2
Hypercalcemia  1 [3]  0/24 (0.00%)  0 4/26 (15.38%)  4
Hypernatremia  1 [4]  0/24 (0.00%)  0 0/26 (0.00%)  0
Hyponatremia  1 [5]  0/24 (0.00%)  0 0/26 (0.00%)  0
Hyperchloremia  1 [6]  3/24 (12.50%)  3 7/26 (26.92%)  7
Nervous system disorders     
Seizure  1  1/24 (4.17%)  1 2/26 (7.69%)  2
Renal and urinary disorders     
Acute kidney injury  1  0/24 (0.00%)  0 1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1 [7]  7/24 (29.17%)  7 6/26 (23.08%)  6
Skin and subcutaneous tissue disorders     
Rash  1  4/24 (16.67%)  4 4/26 (15.38%)  4
Pressure injury  1  1/24 (4.17%)  1 0/26 (0.00%)  0
Vascular disorders     
Thrombosis  1  0/24 (0.00%)  0 0/26 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
[1]
Hyperlacatatemia > 4 mmol/L
[2]
Hyperkalemia >6 mEq/L
[3]
Hypercalcemia (ionized calcium > 1.35 mEq/L or total calcium > 12 mEq/L)
[4]
Hypernatremia >155 mEq/L
[5]
Hyponatremia <128 mEq/L
[6]
Hyperchloremia >110 mEq/L
[7]
Non-invasive mechanical ventilation
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Scott L. Weiss, study co-PI
Organization: The Children's Hospital of Philadelphia
Phone: 215-590-5505
EMail: WeissS@email.chop.edu
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03340805    
Other Study ID Numbers: 17-013936
First Submitted: November 2, 2017
First Posted: November 14, 2017
Results First Submitted: June 11, 2019
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019