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CTRI Number  CTRI/2016/12/007594 [Registered on: 19/12/2016] Trial Registered Prospectively
Last Modified On: 31/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Comparing two types of commonly used fluids for resuscitation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  
Comparison of 2 resuscitation fluids (balanced salt and normal saline) in children With Septic Shock 
Scientific Title of Study
Modification(s)  
Balanced Salt Solutions vs. Normal Saline in Children With Septic Shock 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NCT02835157  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jhuma Sankar 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room:3055, Department of Pediatrics AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126596784  
Fax    
Email  jhumaji@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jhuma Sankar 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room:3055, Department of Pediatrics AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126596784  
Fax    
Email  jhumaji@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jhuma Sankar 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room:3055, Department of Pediatrics AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126596784  
Fax    
Email  jhumaji@gmail.com  
 
Source of Monetary or Material Support  
AIIMS 
 
Primary Sponsor  
Name  AIIMS 
Address  All India Institute of Medical Sciences Ansari Nagar New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jhuma Sankar  All India Institute of Medical Sciences  Department of Pediatrics AIIMS
South
DELHI 
9818399864

jhumaji@gmail.com 
Ramesh Kumar  JIPMER  JIPMER Dhanvantari Nagar Puducherry
Pondicherry
PONDICHERRY 
7373739142

krramesh_iway@yahoo.co.in 
Jayashree Muralidharan  Postgraduate Institute of Medical education and Research  Department of Pediatrics PGIMER, Chandigarh
Chandigarh
CHANDIGARH 
01722755629

mjshree@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
IEC  Approved 
IEC  Approved 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Children 2 month to ≤ 15 years with features of septic shock , (1) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Balanced saline at 20 ml/kg as bolus over 15-20 minutes.   Balanced salt solutions or crystalloids have sodium concentrations resembling that of plasma, low chloride concentrations, organic anions such as L-lactate, acetate, gluconate, malate, succinate and other potential HCO3 substitutes such as pyruvate, Beta-OH butyrate. 
Comparator Agent  Normal saline as boluses at 20 ml/kg over 15-20 minutes  Normal saline contains equal amounts of sodium and chloride (156 meq/L each) and is the currently recommended fluid for initial resuscitation.  
 
Inclusion Criteria  
Age From  60.00 Day(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children 2 month to ≤ 15 years with features of shock requiring at least two fluid boluses (20 ml/kg) would be included.  
 
ExclusionCriteria 
Details  1. Children with cardiogenic shock
2. Known patient with chronic kidney disease with baseline deranged renal function (eGFR < 90 ml/1.73 m2/min)
3. Severe malnutrition
4. Children whose parents refuse to give an informed consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Proportion of children with acute kidney injury  1st 7 days after initial fluid resuscitation 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in pH, serum bicarbonate and strong ion difference   1. At baseline and 6 hours
2. At Baseline and 24 hours
 
Proportion of patients with serum chloride levels 108 meq/L   At 6 and 24 hours  
Total fluids received as boluses   In first 6 and 24 hours 
Mortality   During ICU stay 
 
Target Sample Size
Modification(s)  
Total Sample Size="708"
Sample Size from India="708" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="708" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/01/2017 
Date of Study Completion (India) 31/01/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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 hypercholremia 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. 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, we decided to compare the two solutions on the incidence of acute kidney injury in the first 7 days in children resuscitated with either of the two fluids. Children receiving volumes of atleast 40 ml/kg in the first hour of resuscitation as boluses would be enrolled and followed up for the proposed outcome variables till death/discharge. We plan to enrol 708 subjects over a period of 3 years. We believe that the proposed study will provide the definitive answer to the optimum crystalloid to be used for fluid resuscitation in children with shock due to hypovolemia or sepsis. 

 
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