NCT06026267 Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
| NCT ID | NCT06026267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Condition | Liver Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-10-10 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-10-10 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined, which decreases the morbidity and mortality. However the conventional dose recommended by the guidelines is usually not tolerated by the Indian population. Investigator propose that the low dose is as beneficial as the standard dose in patients with high risk SBP in the prevention/progression of renal dysfunction in cirrhotic patients with high risk spontaneous bacterial peritonitis. If confirmed, these results could support a significant cost reduction in the management of ascites in cirrhotic patients and decrease the side effects of the volume overload in the patient of the cirrhosis.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06026267 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06026267 currently recruiting?
Yes, NCT06026267 is actively recruiting participants. Contact the research team at saurav.paul79@gmail.com for enrollment information.
Where is the NCT06026267 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT06026267 clinical trial?
NCT06026267 is sponsored by Institute of Liver and Biliary Sciences, India. The trial plans to enroll 300 participants.