| CTRI Number |
CTRI/2024/10/074654 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Fluid Management Strategies in Critically Ill Children on Ventilators whether Less Fluid Improve Survival or not. |
|
Scientific Title of Study
|
Restricted versus liberal maintenance fluid
Strategy in mechanically ventilated children: A open-label
Randomized control trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samiksha |
| Designation |
Pediatric Junior Resident |
| Affiliation |
Department of Pediatrics All India Institute of Medical Sciences Raipur |
| Address |
Pediatric Intensive Care Unit (2C3 Ward), C block 2nd floor Department of Pediatrics All India Institute of Medical Sciences Raipur Gate No 1 Great Eastern Road AIIMS campus Tatibandh Raipur
Gate No 1 Great Eastern Road AIIMS campus Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9350596381 |
| Fax |
|
| Email |
samikshabalhara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Jindal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Pediatric Intensive Care Unit (2C3 Ward), C block 2nd floor Department of Pediatrics All India Institute of Medical Sciences Raipur Gate No 1 Great Eastern Road AIIMS campus Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8224014667 |
| Fax |
|
| Email |
dratuljindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Jindal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Pediatric Intensive Care Unit (2C3 Ward), C block 2nd floor Department of Pediatrics All India Institute of Medical Sciences Raipur Gate No 1 Great Eastern Road AIIMS campus Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8224014667 |
| Fax |
|
| Email |
dratuljindal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Raipur Gate No 1 Great Eastern Road AIIMS campus Tatibandh Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
All India Institute of Medical Sciences Raipur Gate No 1 Great Eastern Road AIIMS campus Tatibandh Raipur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samiksha |
AIIMS RAIPUR |
Pediatric Intensive Care Unit (PICU),2c3 WARD, C BLOCK 2nd floor, Department of Pediatrics, Gate no 1 ,Great eastern road,opposite Gurudwara,AIIMS campus,Tatibandh,Raipur,Chattisgarh 492099
Raipur
CHHATTISGARH
Raipur
CHHATTISGARH |
9350596381
samikshabalhara@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ehics Commitee,All India Institute of Medical Sciences,Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B96||Other bacterial agents as the cause of diseases classified elsewhere, (2) ICD-10 Condition: J09-J18||Influenza and pneumonia, (3) ICD-10 Condition: R00-R09||Symptoms and signs involving the circulatory and respiratory systems, (4) ICD-10 Condition: G35-G37||Demyelinating diseases of the central nervous system, (5) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maintenance fluids (including regular drugs and infusions) will be 50% of estimated using Holliday segar formula |
One group will be restricted maintenance fluid fifty percent.Maintenance fluids (including regular drugs and infusions) will be 50% of estimated using Holliday segar formula |
| Comparator Agent |
Maintenance fluids (including regular drugs and infusions) will be 70% of estimated using Holiday Segar formula |
One group will be liberal maintenance fluid of seventy percent.Maintenance fluids (including regular drugs and infusions) will be 70% of estimated using Holiday Segar formula |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1-month to 15-years who are mechanically ventilated for at least 48 hours and hemodynamically stable |
|
| ExclusionCriteria |
| Details |
Cardiac disease, kidney disease, DKA, DI, severe dehydration, SAM, sickle cell crisis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PICU mortality |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PeLOD score
|
1-7 |
| Cumulative fluid overload |
Day 7 |
| Ventilator free days (VFD) |
28 days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In paediatric critical care, maintaining intravascular volume is crucial for optimal organ perfusion. Fluid is the second most common drug prescribed to an intensive care setting after oxygen. It is a double-edged sword due to its narrow therapeutic index. Traditional Holliday-Segar (HS) formula for calculation of maintenance fluid overestimates daily requirement of mechanically ventilated children who are non-ambulatory and with significantly less insensible losses. Primary objective of this study is to assess effect of conservative maintenance fluid strategy (50% of HS formula) on mortality in mechanically ventilated children compared to liberal fluid strategy (70% of HS formula). It will be a single-centre, open-label, randomize controlled trial with an estimated sample size of 92 (1:1 allocation). Randomization sequence will be computer generated and executed through opaque, sealed envelopes. Children meeting the inclusion and exclusion criteria will be tracked through first 7 days of their PICU stay to assess for fluid overload, ventilator free days and multi-organ dysfunction. 28-day mortality will be recorded. Data analysis will be performed using IBM SPSS. Continuous variables will be described as median with interquartile range. Categorical variables will be described as proportions. Intention-to-treat analysis will be performed. |