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OpenTrials
Completed

NCT Number: NCT01578226

Procalcitonin in Cirrhotic Patients at High Risk for Sepsis

Infections are frequent life-threatening events in patients with cirrhosis, occurring at least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no clear-cut clinical and biochemical features are helpful in diagnosing and prognostically stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker presenting high sensibility and specificity in diagnosing bacterial infections in different clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.

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Key information

Conditions

Cirrhosis Ascites Bacterial Infections Bacterial Infections and Mycoses Fibrosis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology Unit - University Hospital of Modena

Modena, 41124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • liver cirrhosis regardless of aetiology
  • clinically relevant ascitic decompensation at time of hospital admission

Exclusion criteria

  • high haematic ascites
  • ongoing antimicrobial therapy or stopped less than 7 days before admission
  • last hospital discharge within 7 days
  • surgery or trauma within 30 days from enrolment
  • hepatocellular carcinoma out of Milan criteria
  • extra hepatic malignancies
  • immunodeficiency syndrome
  • pregnancy

Sponsors and collaborators

Lead sponsor

Prof. Facchinetti Fabio

Other

Registry information

Official study title

Role of Procalcitonin (PCT) for the Diagnosis of Sepsis in Ascitic Cirrhotic Patients

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 16, 2012
Registry last updated
Apr 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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