Skip to content

Comparison of the effect of intravenous administration of PlasmaLyte A versus Normal saline on serum chloride levels in children

Plasma-Lyte-A versus Normal Saline for intravenous fluid therapy in children: A Randomized Controlled Trial - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080980
Enrollment
438
Registered
2025-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: B999- Unspecified infectious disease Health Condition 2: E46- Unspecified protein-calorie malnutrition Health Condition 3: G969- Disorder of central nervous system, unspecified Health Condition 4: J22- Unspecified acute lower respiratory infection Health Condition 5: K929- Disease of digestive system, unspecified Health Condition 6: Q209- Congenital malformation of cardiacchambers and connections, unspecified Health Condition 7: N29- Other disorders of kidney and ureter in di

Interventions

Intervention1: Plasmalyte A: At the time of enrolment, baseline data will be recorded in a proforma. This will include name, gender, diagnosis, any significant history, previous hospitalization, dis

Sponsors

Jawaharlal Nehru Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Admitted to PICU or emergency due to medical conditions. 2. Need for intravenous fluid administration 3. Serum sodium more than 130 mmol/L (measured on admission or no longer than 48 h before randomization)

Exclusion criteria

Exclusion criteria: 1. Pre-existing conditions like cardiac conditions and chronic kidney disease. 2. Disease-specific IVF protocols - Traumatic brain injury or at risk of cerebral edema, Burns, Post-liver transplant, post-renal transplant, Diabetic ketoacidosis, Oncology patients needing hyperhydration. 3. Blood sugar less than 60 mg/dl at the time of start of intervention and during 48 hours of intervention.

Design outcomes

Primary

MeasureTime frame
Increase in serum chloride by at least 5 mmol/LTimepoint: At baseline and at the end of 48 hours from the beginning of the infusion of intervention/comparator agents

Secondary

MeasureTime frame
1. New-onset acute kidney injury (AKI). 2. Length of PICU stay 3. Length of hospital stay. 4. PICU-free survival. Timepoint: New onset AKI within 48 hours of beginning of intervention/comparator agents

Countries

India

Contacts

Public ContactArshad P

Jawaharlal Nehru Medical College

drkafzal@hotmail.com05712721182

Outcome results

None listed

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