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Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation

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ClinicalTrials.gov Identifier: NCT03133767
Recruitment Status : Completed
First Posted : April 28, 2017
Results First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Nicholas M Mohr, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Fluid Loss
Symptom Complex, Triple
Emergencies
Interventions Drug: Lactated Ringer Solution
Drug: Normal Saline 0.9% Infusion Solution Bag
Enrollment 157

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lactated Ringers Solution Normal Saline Solution
Hide Arm/Group Description

Participants in this arm will receive two liters of IV Lactated Ringer’s solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay

Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV

Period Title: Overall Study
Started 79 78
Completed 41 53
Not Completed 38 25
Reason Not Completed
Lost to Follow-up             38             24
Protocol Violation             0             1
Arm/Group Title Lactated Ringers Solution Normal Saline Solution Total
Hide Arm/Group Description

Participants in this arm will receive two liters of IV Lactated Ringer’s solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay

Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV

Total of all reporting groups
Overall Number of Baseline Participants 41 53 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 41 participants 53 participants 94 participants
29
(22 to 41)
39
(25 to 45)
35
(23 to 44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 53 participants 94 participants
Female
34
  82.9%
24
  45.3%
58
  61.7%
Male
7
  17.1%
29
  54.7%
36
  38.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 53 participants 94 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   7.3%
0
   0.0%
3
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   4.9%
7
  13.2%
9
   9.6%
White
34
  82.9%
45
  84.9%
79
  84.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   4.9%
1
   1.9%
3
   3.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 53 participants 94 participants
41 53 94
1.Primary Outcome
Title Quality of Recovery-40 Score at 24 Hours
Hide Description The Quality of Recovery-40 (QoR-40) is a validated instrument that quantifies patient’s self-assessment of functional recovery, symptoms, and physical comfort. The QoR-40 scores range from 40 to 200 with a 200 representing a better recovery outcome. The survey consists of 40 questions scored from one to five with a Likert scale, and the total score is the sum of each question.
Time Frame 24 hours after ED visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactated Ringers Solution Normal Saline Solution
Hide Arm/Group Description:

Participants in this arm will receive two liters of IV Lactated Ringer’s solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay

Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV

Overall Number of Participants Analyzed 41 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
166.8
(160.5 to 173.1)
164.4
(157.8 to 171.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactated Ringers Solution, Normal Saline Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.608
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Quality of Recovery-40 Score After Administration
Hide Description The Quality of Recovery-40 (QoR-40) is a validated instrument that quantifies patient’s self-assessment of functional recovery, symptoms, and physical comfort. The QoR-40 scores range from 40 to 200 with a 200 representing a better recovery outcome. The survey consists of 40 questions scored from one to five with a Likert scale, and the total score is the sum of each question.
Time Frame Immediately after fluid administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactated Ringers Solution Normal Saline Solution
Hide Arm/Group Description:

Participants in this arm will receive two liters of IV Lactated Ringer’s solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay

Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV

Overall Number of Participants Analyzed 41 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
152.6
(145.3 to 159.9)
141.6
(133.5 to 149.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactated Ringers Solution, Normal Saline Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants That Filled an ED Prescription
Hide Description Seven days after study enrollment, participants were asked by text message, “Have you filled any prescriptions from the emergency department?”
Time Frame 7 days after study enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants that received an ED prescription and responded to the seven-day text message were included in this analysis (26 participants in the LR and 25 in the NS group).
Arm/Group Title Lactated Ringers Solution Normal Saline Solution
Hide Arm/Group Description:

Participants in this arm will receive two liters of IV Lactated Ringer’s solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay

Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV

Overall Number of Participants Analyzed 26 25
Measure Type: Count of Participants
Unit of Measure: Participants
14
  53.8%
19
  76.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactated Ringers Solution, Normal Saline Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants That Returned to the ED Within 7 Days for the Same Complaint
Hide Description Seven days after study enrollment, participants were asked by text message, “Have you returned to the emergency department for the same problem?”
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Response rates for the secondary outcomes were 47.4% (n=36) in the NS group and 53.3% (n=42) in the LR group.
Arm/Group Title Lactated Ringers Solution Normal Saline Solution
Hide Arm/Group Description:

Participants in this arm will receive two liters of IV Lactated Ringer’s solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay

Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV

Overall Number of Participants Analyzed 42 36
Measure Type: Count of Participants
Unit of Measure: Participants
5
  11.9%
7
  19.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactated Ringers Solution, Normal Saline Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Participants That Sought Care From Another Healthcare Provider for the Same Complaint
Hide Description Seven days after study enrollment, participants were asked by text message, “Have you seen another medical provider for the same complaint?”.
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Response rates for the secondary outcomes were 47.4% (n=36) in the NS group and 53.3% (n=42) in the LR group.
Arm/Group Title Lactated Ringers Solution Normal Saline Solution
Hide Arm/Group Description:

Participants in this arm will receive two liters of IV Lactated Ringer’s solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay

Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV

Overall Number of Participants Analyzed 42 36
Measure Type: Count of Participants
Unit of Measure: Participants
9
  21.4%
7
  19.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactated Ringers Solution, Normal Saline Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.509
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Participants could be assessed for adverse events at the phone call 24-48 hours following study enrollment and/or at the text message seven days following study enrollment.
Adverse Event Reporting Description Participants responding to the 24-hour phone call and/or the seven-day text could be assessed for adverse events. Therefore, the total of participants in the LR group is 42 (one participant did not respond to the primary outcome, but did respond to the seven-day text to assess secondary outcomes).
 
Arm/Group Title Lactated Ringers Solution Normal Saline Solution
Hide Arm/Group Description

Participants in this arm will receive two liters of IV Lactated Ringer’s solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay

Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV

All-Cause Mortality
Lactated Ringers Solution Normal Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/53 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lactated Ringers Solution Normal Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lactated Ringers Solution Normal Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/53 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Nicholas Mohr
Organization: University of Iowa
Phone: 319-384-8285
Responsible Party: Nicholas M Mohr, University of Iowa
ClinicalTrials.gov Identifier: NCT03133767     History of Changes
Other Study ID Numbers: 201701764
First Submitted: April 25, 2017
First Posted: April 28, 2017
Results First Submitted: May 29, 2018
Results First Posted: September 11, 2018
Last Update Posted: September 11, 2018