Comparing low dose and conventional dose albumin for patients with liver cirrhosis and high risk of infection
Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
NA · Institute of Liver and Biliary Sciences, India · NCT06026267
This study is testing whether a lower dose of albumin can help people with liver cirrhosis and a high risk of infection just as well as the regular dose, to see if it can be safer and cheaper.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India (other) |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT06026267 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of low dose albumin compared to conventional dose albumin in patients with liver cirrhosis who are at high risk for developing acute kidney injury due to spontaneous bacterial peritonitis. The study will enroll 300 patients aged over 18 years, randomly assigning them to receive either the low or conventional dose of albumin. The primary outcome will be the development or progression of acute kidney injury by day 4. The trial is designed to determine if the low dose is as effective as the standard dose, potentially leading to reduced costs and side effects for patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with liver cirrhosis and spontaneous bacterial peritonitis at high risk for acute kidney injury.
Not a fit: Patients with significant cardiac or pulmonary disease, known chronic kidney disease, or other serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more cost-effective treatment option for patients with liver cirrhosis and high risk of kidney injury.
How similar studies have performed: While the use of albumin in similar contexts has been explored, this specific comparison of low versus conventional dosing in this population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>18years 2. Cirrhosis with SBP (community acquired /Health care associated/ nosocomial) 3. High risk SBP : Patients with S Bil \>4 mg/dL and/or s creat \> 1 mg/dl at presentation Exclusion Criteria: 1. Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin) 2. Significant cardiac failure, pulmonary disease 3. Known CKD or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG) 4. Hepatocellular carcinoma 5. HIV infection 6. GI bleed within 1 month before the study 7. Grade 3 to 4 hepatic encephalopathy 8. Shock (MAP \< 65) 9. Serum creatinine level of \> 3 mg/decilitre 10. Presence of any potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment within one week before the diagnosis of SBP).
Where this trial is running
New Delhi, National Capital Territory of Delhi
- Institute of Liver & Biliary Sciences — New Delhi, National Capital Territory of Delhi, India (RECRUITING)
Study contacts
- Study coordinator: Dr Saurav Paul, MD
- Email: saurav.paul79@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Cirrhosis, Spontaneous Bacterial Peritonitis