Status:
COMPLETED
Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Spontaneous Bacterial Peritonitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
AIM:- A randomized non-inferiority trial comparing low dose albumin versus standard dose albumin in high risk Spontaneous Bacterial Peritonitis. Methodology In this non-inferior randomized controlled...
Eligibility Criteria
Inclusion
- \>18 years of age
- Cirrhosis with SBP (community acquired, health care associated and nosocomial) and baseline serum bilirubin ≥4 mg/dl and/or SCr ≥ 1 mg/dl.
Exclusion
- Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- Significant cardiac failure, pulmonary disease
- Known CKD ( Chronic Kidney Disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or Abnormal findings on renal USG)
- Hepatocellular carcinoma
- HIV (Human Immunodeficiency Virus) infection;
- GI (Gastrointestinal) bleed within 1 month before the study
- Ileus
- Grade 3 to 4 hepatic encephalopathy
- Other types of infection
- Shock
- Presence of any potential causes of dehydration (such as diarrhoea or an intense response to diuretic treatment) within one week before the diagnosis of SBP).
- Baseline serum bilirubin \<4 mg/dl or S. Cr \< 1 mg/dl
- Serum creatinine level of \> 3.0 mg/dl.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04273373
Start Date
March 1 2020
End Date
December 31 2020
Last Update
May 10 2022
Active Locations (1)
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1
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070