| CTRI Number |
CTRI/2023/10/059358 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial comparing whether giving less intravenous fluid than usual in mechanically ventilated children is associated with better outcomes. |
|
Scientific Title of Study
|
Impact of protocolized restrictive versus liberal/usual maintenance fluid strategy on fluid overload among mechanically ventilated children: an open-label randomized trial (ReLiSCh-II trial) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujith Mathew John |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research PGIMER |
| Address |
Dr. Sujith Mathew John,
Junior Resident,
Advanced Pediatric Centre,
Post-graduate Institute of Medical Education and Research PGIMER,
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8825563493 |
| Fax |
|
| Email |
sujithmathewjohn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujith Mathew John |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research PGIMER |
| Address |
Dr. Sujith Mathew John,
Junior Resident,
Advanced Pediatric Centre,
Post-graduate Institute of Medical Education and Research PGIMER,
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8825563493 |
| Fax |
|
| Email |
sujithmathewjohn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujith Mathew John |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research PGIMER |
| Address |
Dr. Sujith Mathew John,
Junior Resident,
Advanced Pediatric Centre,
Post-graduate Institute of Medical Education and Research PGIMER,
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8825563493 |
| Fax |
|
| Email |
sujithmathewjohn@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Suresh Kumar |
| Address |
Dr. Suresh Kumar,
Associate Professor,
Department of Pediatrics,
Advanced Pediatric Centre,
Post-graduate Institute of Medical Education and Research PGIMER,
Chandigarh
CHANDIGARH |
| Type of Sponsor |
Other [Self] |
|
|
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 Suresh Kumar |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
Pediatric Intensive Care Unit,
Advanced Pediatric Centre,
Postgraduate Institute of Medical Education and Research, Chandigarh - 160012
Chandigarh
CHANDIGARH |
9855373969
sureshangurana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), Postgraduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Liberal (Usual) maintenance fluid group |
70-80% maintenance fluids as calculated by Holliday-Segar formula.
Duration: 5 days from enrollment. |
| Intervention |
Protocolized restrictive maintenance fluid group |
40-50% maintenance fluids as calculated by Holliday-Segar formula. In addition, children with Fluid overload % (FO%) more than 10% will be started on Furosemide infusion at 0.1 mg/kg/hour until FO% less than 10%. Duration: 5 days from enrollment. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All children between the age group of 3 months to 12 years who are mechanically ventilated (with anticipated mechanical ventilation for ≥48 hours) and have been haemodynamically stable for 6 hours prior to enrolment (no requirement for fluid boluses or increase in vasoactive drugs over the past 6 hours). |
|
| ExclusionCriteria |
| Details |
1. Haemodynamically unstable children (requirement of fluid boluses or increase in vasoactive drugs over the past 6 hours)
2. Diarrhoea with dehydration
3. Acute kidney injury
4. Need of renal replacement therapy at admission
5. Known congenital or acquired cardiac disease
6. Chronic liver, lung, or kidney disease
7. Inborn errors of metabolism
8. Diabetic ketoacidosis
9. Known syndrome of inappropriate ADH secretion (SIADH), cerebral salt wasting (CSW) or diabetes insipidus
10. Consent refusal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion with fluid overload percentage (FO%) >10% |
Within first 5 days of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Daily fluid overload% (FO%) till day 5 |
Day 1 to Day 5 |
| IVC diameter and IVC variability index |
48 hours |
| N-terminal pro-Brain natriuretic peptide (NT-proBNP) |
48 hours |
| Safety parameters – requirement for fluid boluses, change in fluid prescription, vasoactive agents and daily Vasoactive Inotrope Score (VIS). |
Day 1 to Day 5 |
| Ventilator Free Days (VFDs) |
Day 28 |
| PICU Free Days (PFDs) |
Day 28 |
| Mortality |
Day 28 |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/11/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fluid overload of >10% has been shown to be associated with adverse outcomes in mechanically ventilated patients. This study is a randomized, open-label trial comparing the impact of protocolized restrictive versus liberal/usual maintenance fluid strategy on fluid overload among mechanically ventilated children. 130 children (3 months-12 years) who are mechanically ventilated for any indication and have been haemodynamically stable for 6 hours prior to enrollment, with none of the exclusion criteria, will be randomized to receive either "Protocolized restrictive" or "Liberal/Usual" maintenance fluids. Children in the protocolized restrictive group will receive 40-50% maintenance fluids with de-resuscitation with Furosemide infusion if fluid overload percentage (FO%) > 10%; Children in the liberal/usual group will receive 70% maintenance fluids as per unit protocol. The primary outcome will be the proportion with FO% > 10% within 5 days after enrollment. Secondary outcomes will be daily FO% till day 5, inferior vena cava (IVC) diameter and IVC variability index at 48 hours, N-terminal pro-brain natriuretic peptide (NT-proBNP) at 48 hours, safety parameters, ventilator free days and PICU-free days at day 28, and mortality in 28 days. |