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Completed

NCT Number: NCT02085915

Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast.

Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.

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Key information

Conditions

Cirrhosis Fibrosis Infection Infections Liquid of Ascites Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Jolimont, Haine-Saint-Paul, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female over 18 years
  • Presence of ascites due to cirrhosis
  • Hospitalization for a complication of cirrhosis (ascites first decompensation, gastrointestinal bleeding, encephalopathy, etc ...).

or

  • Hospitalization to perform a paracentesis evacuated outpatient
  • Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis and with clinical and/or biological signs that suggest spontaneous infection of ascite.

Exclusion criteria

  • Patients with ascites urgently admitted to hospital for suspected infection receiving antibiotics for more than 12 hours.
  • chylous ascites,
  • Hemorrhagic Ascites
  • Biliary Ascites (straw)
  • Ascites heterogeneous appearance
  • Ascites not related to portal hypertension (peritoneal carcinomatosis, pancreatic ascites, tuberculosis, etc ...)
  • Patient receiving imipenem IV.
  • Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis without clinical and/or biological signs that suggest spontaneous infection of ascite.

Treatment and study plan

strip Peri Screen

Other

Primary outcomes

  1. Sensitivity and Specificity

    Time frame: Baseline

    Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis,

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: Per-DRISLA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2014
Registry last updated
May 5, 2026

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

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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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