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Restricted and usual maintenance intravenous fluid therapy in mechanically ventilated children

RESTRICTED VERSUS LIBERAL MAINTENANCE FLUID STRATEGY IN MECHANICALLY VENTILATED CHILDREN: RANDOMIZED OPEN LABEL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/028102
Enrollment
100
Registered
2020-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: Z768- Persons encountering health services in other specified circumstances

Interventions

Intervention1: Restricted maintenance fluids: Intervention arm willl recieve restricted maintenance fluids. The restrictive maintenance fluid is defined as administration of 40% of maintenance fluid e

Sponsors

POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children of 3-month to 12-year age who are mechanically ventilated and hemodynamically stable for at least 6 hours (no requirement of fluid boluses or increase in vasoactive drugs in last 6 hours)

Exclusion criteria

Exclusion criteria: 1 Hemodynamic unstable children who require continuous fluid resuscitation and hike in vasoactive drugs 2 Anticipated mechanical ventilation for 3 Diabetic ketoacidosis 4 Diarrhoea with dehydration 5 Congenital or acquired cardiac disease 6 Acute kidney injury 7 Post-operated children 8 Need of RRT at admission 9 Chronic disorders: Chronic liver disease, kidney disease, or lung disorders 10 Children with known diabetes insipidus, cerebral salt wasting, and syndrome of inappropriate secretion of antidiuretic hormone 11 Increased intracranial pressure 12 Hypoglycemia

Design outcomes

Primary

MeasureTime frame
Fluid overload percentage in restricted and liberal maintenance fluid groups on day 7 of PICU stay.Timepoint: Day 7

Secondary

MeasureTime frame
1 Vasoactive Ionotropic score (VIS) on Day 1-7 2 Organ dysfunction score SOFA/PELOD on Day 1-7 3 Oxygenation index on Day 1-7 4 Requirement for RRT 5 Ventilation free days at Day 28 6 PICU free days at Day 28 7 Mortality Timepoint: Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 28

Countries

India

Contacts

Public ContactSuresh Kumar Angurana

POST-GRADUATE INSTITUTE OF MEDICAL EDUCATION and RESEARCH CHANDIGARH

sureshangurana@gmail.com9855373969

Outcome results

None listed

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