Status:
COMPLETED
Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Fondo de Investigacion Sanitaria
Conditions:
Cirrhosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important...
Detailed Description
Recent studies have shown that the administration of cefotaxime (first choice treatment for SBP) associated with plasma volume expansion with albumin in patients with SBP, was more efficient to preven...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years;
- Cirrhosis defined by clinical, analytical or histological criteria;
- Active infection defined by the presence of at least two of the criteria for systemic inflammatory response syndrome (SIRS), necessarily including neutrophilia in the hemogram. In case of a positive culture, the presence of only one of the SIRS criteria is considered sufficient for the infection diagnosis. SIRS is defined by: temperature \>38º or \<36º C, heart beat \>90 beats/min, breath frequency \>20 resp/min, white cell count \>12000/mm3 or \<4000/mm3 or \>6% of immature cells.
- Written informed consent.
- Absence of the exclusion criteria described below
Exclusion
- Use of antibiotics during the week preceding the study, except for prophylaxis of spontaneous bacterial peritonitis;
- Hepatocarcinoma: hepatocarcinoma patients presenting more than 3 nodes \> 3 cm, or one node larger than 5 cm, tumoral portal thrombosis or extrahepatic tumor extension;
- Heart insufficiency or advanced chronic obstructive pulmonary disease;
- Digestive bleeding during the week preceding the study;
- Presence of septic shock, defined as: sepsis with hypotension (systolic pressure \<90 mm Hg or a decrease \>40 mm Hg as compared to the basal pressure), in spite of an adequate liquid reposition, signs of a poor peripheral perfusion or need of vasoactive drugs;
- Plasma creatinine \> 3 mg/dL;
- Severe dehydration (defined by a central venous pressure \< 3 cm H2O due to severe diarrhea or to a strong response to diuretic treatment) at inclusion in the study; the patients with PVC lower than 3 will receive plasma volume expansion with saline and will be reevaluated within 24 h. If the expansion is able to correct PVC (defined as PVC \> 3), the patients will be apt to be included in the study.
- Existence of diseases which can influence the short term survival.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00124228
Start Date
November 1 2004
End Date
October 1 2008
Last Update
May 27 2010
Active Locations (1)
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1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036