| 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
|
|
|
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
|
|
|
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
|
|
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. |