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Effect of reduced water intake and removing excess body water actively by medicine increasing urine output on critically ill children

Effect of fluid restriction and active fluid removal versus conventional fluid therapy on morbidity in ventilated pediatric patients:an open label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015456
Enrollment
252
Registered
2018-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: I958- Other hypotension

Interventions

Intervention1: Fluid restriction and active fluid removal: 1. Ventilated pediatric patients will be enrolled 2. The positive balance accumulated will be measured by daily weight 3. Once hemodynamicall

Sponsors

Dr Kaushik Maulik
Lead Sponsor
Dr Narayanan P
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. All ventilated children between 2 completed months and 7 completed years admitted to PICU will be included 2. The included children must have received at least one fluid bolus 3. Must have achieved hemodynamic stability at enrolment defined by: MAP >5th centile CRT Not required any more fluid bolus or inotropes in last 12 hours

Exclusion criteria

Exclusion criteria: 1. Child with severe acute malnutrition (SAM) 2. Child with decompensated chronic liver disease and chronic kidney disease on RRT 3. Child with clinically suspected cardiogenic shock/myocarditis/acquired and congenital heart diseases in CCF 4. Children undergoing treatment for raised ICP with fluid restriction 5. Children with no evidence of fluid overload as assessed by body weight(defined as 10% increase from admission weight) 6. Children with severe anemia and hypoalbuminemia

Design outcomes

Primary

MeasureTime frame
To compare the outcome of mechanically ventilated children undergoing fluid restriction and active fluid removal as compared to those with conventional fluid management in terms of daily Pediatric logistic organ dysfunction score (PELOD)Timepoint: This will be measured till 48 hours of sustaining nil balance or cessation of mechanical ventilation in the intervention group or till cessation of mechanical ventilation in the control group

Secondary

MeasureTime frame
1. ICU mortality 2. Duration of PICU stay 3. Ventilator free days 4. Requirement of RRTTimepoint: These will be measured till child is shifted out of PICU

Countries

India

Contacts

Public ContactKAUSHIK MAULIK

Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry

narayanan.p@jipmer.edu.in9443458850

Outcome results

None listed

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