The INFECIR-2 Albumin Prevention Study (NCT02034279) | Clinical Trial Compass
TerminatedPhase 4
The INFECIR-2 Albumin Prevention Study
Stopped: Low recruitment rate and expiration of the study drug
Spain136 participantsStarted 2014-05
Plain-language summary
The aim of this study is to evaluate whether albumin administration improves short-term survival in patients with advanced cirrhosis and bacterial infections other than Spontaneous Bacterial Peritonitis (SBP).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Cirrhotic patients with age ≥18 years
* Diagnosis of urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection at hospital admission or during hospitalization
* Patients with uncomplicated urinary infections or suspected bacterial infection will require the presence of signs of systemic inflammation: at least 1 diagnostic criterion of systemic inflammatory response syndrome (SIRS) and serum CRP levels ≥1 mg/dl (10 mg/L). This criterion will not be required for the rest of infections
* Analytical data of renal and/or liver dysfunction (serum creatinine ≥ 1.2 mg/dl, serum sodium ≤ 130 mEq/l, serum bilirubin ≥4 mg/dl). Patients with pneumonia or documented bacteremia (positive blood cultures) will require the presence of at least 1 of these analytical criteria to be included in the study. Patients with urinary infection, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will require 2 or more criteria for inclusion
Exclusion Criteria:
* \> 72h after infection diagnosis
* Pregnancy
* Acute or subacute liver failure without underlying cirrhosis
* Septic shock
* Severe acute respiratory distress syndrome (Pa02/Fi02 ≤ 100)
* Active or recent variceal bleeding unless controlled for \> 48h
* Ongoing type-1 HRS (past IAC criterion: serum creatinine ≥ 2.5 mg/dl)
* Type-3 ACLF (defined according to the Canonic Study criteria)
* Hemodialysis or othe…