Low-dose Albumin Solution in SBP: a Randomized Double-blind Pilot Study

NCT00852800 | Unknown Phase 2

• 1 other identifier: 05-352
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Spontaneous bacterial peritonitis (SBP) is a common and severe complication of cirrhosis. The most serious complication of SBP is the hepatorenal syndrome (HRS), which occurs in up to 30 percent of patients, with high mortality. Intravenous albumin (1.5 g/kg at diagnosis and 1 g/kg 48 hours later - standard regimen) helps to prevent HRS and improves survival. No information exists on the efficacy of lower doses of albumin. This study was designed to allow direct comparison among different doses of intravenous albumin in patients with SBP - standard (SR) vs dose reduced regimen (DRR) - in order to prevent renal failure and mortality.

Conditions

Renal Impairment; All Cause Mortality

Keywords

spontaneous bacterial peritonitis; albumin; renal impairment; mortality

Outcome Measures

Primary Outcomes (2)

• renal impairment

  within first 90 days

• all cause mortality

  within first 90 days

Secondary Outcomes (1)

• Plasmatic renin activity

  day 0 and 7

Study Arms (2)

Standard regimen

ACTIVE COMPARATOR

Albumin in standard regimen (1.5 g/Kg IV on day 1 and 1 g/kg IV on day 3)with saline solution to complete total volume of 1000 ml on day 1 and 500 ml on day 3

Drug: Albumin

Dose reduced regimen

EXPERIMENTAL

Albumin in dose reduced regimen (1 g/kg IV on day 1 and 0.5 g/kg IV on day 3) with saline solution to complete total volume of 1000 ml on day 1 and 500 ml on day 3

Drug: Albumin

Interventions

Albumin DRUG

1.5 g/kg IV on day 1 and 1 g/kg IV on day 3 with saline solution to complete total volume of 1000 ml on day 1 and 500 ml on day 3. Infusion in 4 hours.

Also known as: Albumin at standard dose diluted with saline solution

Standard regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cytological diagnosis of spontaneous bacterial peritonitis
• age between 18 and 80 years
• written informed consent

You may not qualify if:

• findings suggestive of secondary peritonitis
• antibiotic treatment within one week before the diagnosis of spontaneous bacterial peritonitis (except for prophylactic treatment with norfloxacin or trimethoprim/sulfamethoxazole)
• other infections, shock, gastrointestinal bleeding, grade 3 or 4 hepatic encephalopathy, cardiac failure, and any disease (e.g., advanced neoplasia) that could affect the short term prognosis
• creatinine level of more than 3 mg per deciliter
• potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment) within one week before the diagnosis of peritonitis

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Albumins; Saline Solution

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mário R Álvares-da-Silva

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Alexandre Araujo

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Gabriela Rossi

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Antônio B Lopes

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: March 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2011
• Last Updated: June 7, 2010

Record last verified: 2010-06

Locations

BR (1)