To study efficacy and safety of low dose albumin infusion in patients of decompensated cirrhosis with Acute Kidney Injury

Efficacy and safety of recommended dose of albumin infusion vs. low dose albumin infusion in patients of decompensated cirrhosis with Acute Kidney Injury - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075488

Enrollment

Registered

2024-10-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: Intervention: 20% human Albumin infusion at a dose of 0.5 gm/ kg body weight per day (maximum daily dose 100gm) for 2 days Control Intervention1: Control: 20% human Albumin infusion at

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of decompensated cirrhosis with Acute kidney injury =Stage IB i.e. Serum creatinine =1.5mg/dl

Exclusion criteria

Exclusion criteria: Pregnancy Advanced Chronic Kidney Disease Shock Prior Kidney or Liver Transplant Acute or chronic Renal Replacement Therapy at the time of enrolment Congestive heart failure ? Known allergy or develops allergic reaction to human albumin

Design outcomes

Primary

Measure	Time frame
The proportion of decompensated cirrhosis patients having acute kidney injury with complete resolution (S. Cr. within 0.3mg/dl of Baseline S. Creatinine) of acute kidney injury after 2 consecutive days of fluid challenge with 20% human albumin at a dose of – 1gm/kg of body weight daily; 0.5gm/kg of body weight dailyTimepoint: After 2 consecutive days of fluid challenge with 20% human albumin at a dose of – 1gm/kg of body weight daily 0.5gm/kg of body weight daily	—

Measure

Time frame

The proportion of decompensated cirrhosis patients having acute kidney injury with complete resolution (S. Cr. within 0.3mg/dl of Baseline S. Creatinine) of acute kidney injury after 2 consecutive days of fluid challenge with 20% human albumin at a dose of – 1gm/kg of body weight daily; 0.5gm/kg of body weight dailyTimepoint: After 2 consecutive days of fluid challenge with 20% human albumin at a dose of – 1gm/kg of body weight daily 0.5gm/kg of body weight daily

—

Secondary

Measure	Time frame
Frequency of adverse events among patients treated with 20% human albumin at a dose of- 1gm/kg of body weight daily; 0.5gm/kg of body weight dailyTimepoint: during hospital stay	—

Countries

India

Contacts

Public ContactDr Ajay Kumar

Delhi University

ajaykumar.aiims@gmail.com9718599226

Outcome results

None listed

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