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A randomized trial to evaluate restricted versus usual or Liberal maintenance fluid Strategy in mechanically ventilated Children (ReLiSCh-M trial).

Restricted versus usual or Liberal maintenance fluid Strategy in mechanically ventilated Children: A multicentric open-label randomized trial (ReLiSCh-M trial). - ReLiSCh-M trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083419
Enrollment
600
Registered
2025-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: J960- Acute respiratory failure

Interventions

Intervention1: Restricted maintenance fluid: Group A will be restricted maintenance fluid group that will receive 40-50% of the normal maintenance fluid. Control Intervention1: Usual/liberal maintenan

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 3-month to 18-years. Mechanically ventilated and hemodynamically stable (definded as no requirement of fluid boluses or increase in vasoactive drugs in last 6 hours).

Exclusion criteria

Exclusion criteria: Anticipated mechanical ventilation for Acute kidney injury (AKI) stage II or III (as per KDIGO) or need of RRT Chronic kidney disease or congenital /acquired heart disease Diabetic ketoacidosis Tumor lysis syndrome or hyperleukocytosis Dysnatremia (serum sodium 155 meq/L) Severe acute malnutrition (SAM)

Design outcomes

Primary

MeasureTime frame
28-day PICU mortalityTimepoint: 28-day of enrolment

Secondary

MeasureTime frame
Cumulative FO% ay day 7 of enrolment. Timepoint: Till day 7 of enrolment;Proportion of children with cumulative FO% more than 10%Timepoint: Till day 7 of enrolment;Vasoactive inotropic score (VIS) on day 1-7Timepoint: Till day 7 of enrolment;Sequential organ failure assessment (SOFA) score on day 1-7Timepoint: Till day 7 of enrolment;Pediatric logistic organ dysfunction (PeLOD) score on day 1-7Timepoint: Till day 7 of enrolment;Maximum OI on day 1-7Timepoint: Till day 7 of enrolment;Need of renal replacement therapy (RRT)Timepoint: Till day 28 of enrolment;Ventilator free days (VFD) at day 28Timepoint: Till day 28 of enrolment;PICU free days (PFD) at day 28Timepoint: Till day 28 of enrolment

Countries

India

Contacts

Public ContactSuresh Kumar

PGIMER

sureshangurana@gmail.com9855373969

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026