Efficacy and safety of albumin infusion over one hour versus four hours in children with nephrotic syndrome with edema and hypovolemia: An open-label randomised controlled trial

This study aims to assess efficacy of albumin infusion over one hour versus 4 hours in increasing urine output over 6 hours from initiation of therapy in nephrotic syndrome children, aged 3 to 18 years, with edema and hypovolemia. Rationale behind the study is that rapid albumin infusion leads to higher plasma volume expansion which may help in early restoration of circulatory volume in hypovolemic patients and hence may augment diuresis. Rapid albumin infusion has also shown to increase the half-life of albumin. While studies have shown better efficacy with albumin infusion in children with nephrotic syndrome when given along with diuretics, the safety of albumin infusion given over 1 hour is not well documented.

The pharmacokinetics of albumin may vary in children with nephrotic syndrome due to ongoing proteinuria in relapse state. Data suggests better efficacy of rapid albumin infusion in healthy

individuals but there is dearth of data in children with nephrotic syndrome comparing fast and slow albumin infusions in terms of safety and efficacy. Hence, we aim to compare albumin infusion over 1 hour versus 4 hours.

Patients fulfilling inclusion criteria will be stratified based on biochemical or clinical evidence of hypovolemia and will be randomised to receive 20% albumin infusion either over 1 hour or 4 hours. Patients will be assessed for urine output over 6 hours from initiating the therapy and they will be monitored for any adverse events.