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Comparison of two methods of intravenous fluid administration in sick newborn babies with kidney failure.

Randomized Controlled Trial to compare two maintenance fluid regimens in sick neonates with non-oligouric acute kidney injury.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010761
Enrollment
96
Registered
2017-12-05
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: N179- Acute kidney failure, unspecified

Interventions

Intervention1: Treatment A: Maintenance fluid volume given for replacement of insensible losses plus urine and other losses, volume for volume by intravenous fluid (N/4 dextrose normal saline with pot

Sponsors

Jawaharlal Nehru Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Term and near term (34 weeks or more) sick neonates, birth weight 2000gm or more 2.AKI diagnosed using neonatal modification of KDIGO criteria 3.Non-oliguric i.e. urine output in previous 6 hours of at least 0.5 mL/kg/h 4.Anticipated to receive intravenous fluid for the next 48-72 hours

Exclusion criteria

Exclusion criteria: 1)Major congenital anomalies, known renal anomalies or syndromic baby 2)Receiving drugs that affect fluid and electrolyte balance such as diuretics, mannitol, etc. 3)Refusal to give consent.

Design outcomes

Primary

MeasureTime frame
1. Net fluid balance 2. Proportion of patients with fluid overloadTimepoint: 24, 48 and 72 hours

Secondary

MeasureTime frame
Abnormal renal function at discharge Length of hospital stayTimepoint: At discharge;AKI stage Need for discontinuation of interventionTimepoint: upto 72 hours;Episodes of dyselectrolytemia Number of fluid bolusesTimepoint: 24 hourly;Percentage weight change Urine outputTimepoint: 12 hourly

Countries

India

Contacts

Public ContactNeelkanth Sen

Jawaharlal Nehru Medical College, A.M.U, Aligarh

drkafzal@hotmail.com571-2721182

Outcome results

None listed

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