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

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) - NILL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059358

Enrollment

130

Registered

2023-10-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J969- Respiratory failure, unspecified

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Proportion with fluid overload percentage (FO%) >10%Timepoint: Within first 5 days of enrollment	—

Secondary

Measure	Time frame
Daily fluid overload% (FO%) till day 5Timepoint: Day 1 to Day 5;IVC diameter and IVC variability indexTimepoint: 48 hours;MortalityTimepoint: Day 28;N-terminal pro-Brain natriuretic peptide (NT-proBNP)Timepoint: 48 hours;PICU Free Days (PFDs)Timepoint: Day 28;Safety parameters – requirement for fluid boluses, change in fluid prescription, vasoactive agents and daily Vasoactive Inotrope Score (VIS).Timepoint: Day 1 to Day 5;Ventilator Free Days (VFDs)Timepoint: Day 28	—

Measure

Time frame

Daily fluid overload% (FO%) till day 5Timepoint: Day 1 to Day 5;IVC diameter and IVC variability indexTimepoint: 48 hours;MortalityTimepoint: Day 28;N-terminal pro-Brain natriuretic peptide (NT-proBNP)Timepoint: 48 hours;PICU Free Days (PFDs)Timepoint: Day 28;Safety parameters – requirement for fluid boluses, change in fluid prescription, vasoactive agents and daily Vasoactive Inotrope Score (VIS).Timepoint: Day 1 to Day 5;Ventilator Free Days (VFDs)Timepoint: Day 28

—

Countries

India

Contacts

Public ContactDr Sujith Mathew John

Postgraduate Institute of Medical Education and Research PGIMER

sujithmathewjohn@gmail.com8825563493

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026