A trial comparing whether giving less intravenous fluid than usual in mechanically ventilated children is associated with better outcomes.

Phase 1/2

Not yet recruiting

• Conditions: Respiratory failure, unspecified,

• Registration Number: CTRI/2023/10/059358
• Lead Sponsor: Dr Suresh Kumar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-11
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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).

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion with fluid overload percentage (FO%) >10%	Within first 5 days of enrollment

Secondary Outcome Measures

Name	Time	Method
N-terminal pro-Brain natriuretic peptide (NT-proBNP)	48 hours
Daily fluid overload% (FO%) till day 5	Day 1 to Day 5
IVC diameter and IVC variability index	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

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Suresh Kumar

Principal investigator

9855373969

sureshangurana@gmail.com