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Balanced Salt Solutions vs. Normal Saline in Children With Septic Shock

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ClinicalTrials.gov Identifier: NCT02835157
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : July 31, 2017
Sponsor:
Collaborators:
Postgraduate Institute of Medical Education and Research
Jawaharlal Institute of Postgraduate Medical Education & Research
Information provided by (Responsible Party):
Jhuma Sankar, All India Institute of Medical Sciences, New Delhi

Brief Summary:

Fluid resuscitation is the cornerstone of pediatric shock management; current practices of fluid resuscitation in children are not evidence based. Normal saline is the preferred crystalloid recommended during initial resuscitation in shock, as the incidence of hyponatremia is lower with normal saline compared to all other fluids available and commonly used. However, normal saline has its own set of undesired physicochemical actions. Emerging data strongly indicate the increased incidence of hyperchloremia, metabolic acidosis and consequently, acute kidney injury associated with infusion of large volumes of normal saline. Balanced salt solutions or crystalloids, which have composition resembling plasma but lower chloride concentrations than normal saline, clearly decrease the risk of hyperchloremia and metabolic acidosis in adult as well as pediatric studies when used during the peri-operative period. The results favored balanced solutions in comparison to normal saline. Recent systematic reviews comparing balanced or buffered versus non-buffered fluids for surgery in adults favored the former solution as the metabolic derangements were less with the use of this type of fluid. In adult patients, the two solutions have been compared in various other settings as well such as in traumatic brain injury and in shock. The results favored balanced solutions in comparison to normal saline. However, in the non-surgical setting there is a paucity of evidence on the use of these solutions in children with shock and more evidence needs to be generated to support or refute the use of this fluid as compared to normal saline.

Given this background, the investigators decided to compare the effect of two solutions on the incidence of acute kidney injury in children resuscitated with either of the two fluids. Children receiving volumes of at least 20 ml/kg in the first hour of resuscitation as boluses would be enrolled and followed up for the proposed outcome variables. The investigators plan to enroll 708 patients over a period of 3 years. The investigators believe that the proposed study will provide the answer to the safety of normal saline which is the most widely preferred initial fluid for fluid resuscitation in children with shock due to sepsis.


Condition or disease Intervention/treatment Phase
Septic Shock Shock Drug: Balanced salt solution Drug: Normal saline Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 708 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Balanced Salt Solutions Versus Normal Saline for Initial Fluid Resuscitation in Children With Septic Shock: A Randomized Controlled Trial
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Sodium

Arm Intervention/treatment
Experimental: Balanced salt solution or study group
After enrollment, a fluid bolus comprising of 'balanced saline' solution at a dose of 20 ml/kg over 15-20 minutes with careful monitoring for features of fluid overload would be administered to each child. Fluid resuscitation will be targeted at achieving the therapeutic end points as given in study definitions. A second bolus would be repeated with the same fluid at 20 ml/kg over 15-20 minutes in case therapeutic end points are not reached. After this the management protocol will be as per recommendations of the surviving sepsis campaign guidelines for septic shock in children.
Drug: Balanced salt solution
Balanced salt solutions as boluses of 20 ml/kg would be administered.
Other Names:
  • Sterofundin
  • Isolyte E
  • Plasmalyte 148
  • Compound sodium lactate

Active Comparator: Normal saline or control group
After enrollment, a fluid bolus comprising of 'normal saline' solution at a dose of 20 ml/kg over 15-20 minutes with careful monitoring for features of fluid overload would be administered to each child. Fluid resuscitation will be targeted at achieving the therapeutic end points as given in study definitions. A second bolus would be repeated with the same fluid at 20 ml/kg over 15-20 minutes in case therapeutic end points are not reached. After this the management protocol will be as per recommendations of the surviving sepsis campaign guidelines for septic shock in children.
Drug: Normal saline
Normal saline as boluses of 20 ml/kg would be administered
Other Names:
  • Saline
  • 0.9% saline




Primary Outcome Measures :
  1. Acute Kidney injury defined as increase in serum creatinine by > 0.3mg/dL within 48 hours or to 1.5 times baseline or more within the last 7 days or urine output less than 0.5 mL/kg/h for 6 hours [ Time Frame: From the time of randomization/intervention to 7 days of admission ]
    Incidence of AKI in first 7 days after randomization/ intervention


Secondary Outcome Measures :
  1. Change in pH from baseline to 6, 24, 48, 72 hours and 7 days after randomization [ Time Frame: At admission and at 6, 24, 48, 72 hours and 7 days after randomization ]
    Comparison of change in pH from baseline to upto 7 days after randomization/intervention

  2. Change in serum bicarbonate from baseline to 6, 24, 48, 72 hours and 7 days after randomization [ Time Frame: At admission and at 6, 24, 48, 72 hours and 7 days after randomization ]
    Comparison serum bicarbonate levels from baseline to upto 7 days after randomization/intervention

  3. Proportion of patients with serum chloride levels > 108 meq/L at admission, 6, 24, 48, 72 hours and 7 days after randomization [ Time Frame: At admission and at 6, 24, 48, 72 hours and 7 days after randomization ]
    Incidence of hyperchloremia

  4. Number of fluid boluses received in the first 6 hours after randomization [ Time Frame: From the time of randomization to 6 hours ]
    Total number of fluid boluses received in the first 6 hours after randomization/intervention

  5. Total fluids received in the first 24 hours in ml/kg after randomization [ Time Frame: From the time of randomization to 24 hours ]
    Total fluids received in first 24 hours

  6. Mortality [ Time Frame: From the time of randomization till death or discharge from hospital, whichever came first assessed upto 100 days ]
    Death during ICU course

  7. Time to resolution of AKI [ Time Frame: From the time of onset of AKI after randomization till death or discharge from hospital, whichever came first assessed upto 100 days ]
    Time taken for resolution of AKI

  8. Change in SOFA scores from admission to 24, 48, 72 hours and 7 days after randomization [ Time Frame: At admission and at 24, 48, 72 hours and 7 days after randomization ]
    Comparison of SOFA scores in both groups till 7 days after randomization

  9. Change in PELOD scores from admission to 24, 48, 72 hours and 7 days after randomization [ Time Frame: At admission and at 24, 48, 72 hours and 7 days after randomization ]
    Comparison of PELOD scores in both groups till 7 days after randomization



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Ages Eligible for Study:   2 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 2 month to ≤ 15 years with features of septic shock - defined as children who have a suspected infection manifested by hypothermia or hyperthermia and have at least two clinical signs of decreased perfusion with or without hypotension

Exclusion Criteria:

  • Children receiving fluid boluses before enrollment
  • Children with cardiogenic shock
  • Known patient with chronic kidney disease with baseline deranged renal function (eGFR < 90 ml/1.73 m2/min)
  • Severe malnutrition
  • Children whose parents refuse to give an informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835157


Contacts
Contact: Jhuma Sankar, MD Ped +911126546784 jhumaji@gmail.com
Contact: Rakesh Lodha, MD Ped +911126593621 rlodha1661@gmail.com

Locations
India
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: M C Mishra, Mch NS         
Sub-Investigator: Rakesh Lodha, MD Ped         
Sub-Investigator: Sushil K Kabra, MD Ped         
Principal Investigator: Jhuma Sankar, MD Ped         
PGIMER Recruiting
Chandigarh, India
Contact: Jayashree Muralidharan, MD       mjshree@hotmail.com   
Sub-Investigator: Karthi NY, DM         
JIPMER Recruiting
Puducherry, India, 605006
Contact: Ramesh Kumar, DM       krramesh_iway@yahoo.co.in   
Sub-Investigator: Mahadevan Subramanian, MD         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Postgraduate Institute of Medical Education and Research
Jawaharlal Institute of Postgraduate Medical Education & Research
Investigators
Principal Investigator: Jhuma Sankar, MD Ped All India Institute of Medical Sciences, New Delhi
Study Chair: Sushil K Kabra, MD Ped All India Institute of Medical Sciences, New Delhi
Study Director: Rakesh Lodha, MD Ped All India Institute of Medical Sciences, New Delhi

Responsible Party: Jhuma Sankar, Assistant Professor Pediatrics, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02835157     History of Changes
Other Study ID Numbers: IEC/NP-424/09.10.2015
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jhuma Sankar, All India Institute of Medical Sciences, New Delhi:
Normal saline
Balanced saline
Septic shock
Children
Hyperchloremia
Acute kidney injury

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Plasma-lyte 148
Pharmaceutical Solutions
Ophthalmic Solutions