Trial document




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  DRKS00010664

Trial Description

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Title

INFEKTA Register for infectiological complications of cirrhosis and ascites

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Trial Acronym

INFEKTA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the register is the identification of clinical, immunological and microbiological prognostic factors for improving the individualized management of patients with cirrhosis and ascites.

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Brief Summary in Scientific Language

The aim of the study is to gain a better understanding of the pathogenesis and progression of typical complications in patients with cirrhosis and ascites. Special focus on bacterial infections, especially of spontaneous bacterial peritonitis (SBP), secondary organ failure and immunological peculiarities of patients with cirrhosis and ascites. Ascites is the most common manifestation of hepatic decompensation. The presence of ascites in liver cirrhosis is an urgent indication of an impaired liver function, the presence of significant portal hypertension, leading to an already advanced cirrhosis

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Organizational Data

  •   DRKS00010664
  •   2016/08/04
  •   [---]*
  •   yes
  •   Approved
  •   3188-2016, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   liver cirrhosis
  •   ascites
  •   R18 -  Ascites
  •   K74 -  Fibrosis and cirrhosis of liver
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Interventions/Observational Groups

  •   Non-interventional patient registry. Documentation of health outcome during routine medical Treatment.

    Included will be all patients who are admitted to hospital with liver cirrhosis with significant amounts of ascites. As a part of routine diagnostics ascites and blood as well as urine and stool will be taken.Concomitant medication and comorbidities will documented and evaluated in relation to SBP and other complications.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Mortality within 28 days

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Secondary Outcome

1. mortality within 3 and 12 months

2. frequency of spontaneous bacterial peritonitis

3. Frequency of viral and bacterial infections

4. Spectrum of bacteria in ascites in patients with and without spontaneous bacterial peritonitis

5. Causes and incidence of acute-on-chronic liver failure

6. Change hepatic infections

7. Prevalence of drug interactions

8. Incidence and risk factors of renal failure

9. Influence of the intestinal microbiome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/08/01
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Cirrhosis
- Significant (point expiration) ascites on admission or during the hospitalization
- Inpatient/ outpatient treatment at the Hannover Medical School

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Exclusion Criteria

- Malignant tumor disease (excluding HCC within the Milan criteria)
- Malignant cells in ascites
- Complete Portal vein thrombosis
- HIV infection
- Congenital immunodeficiency
- Condition after organ transplantation (except liver)
- Condition after bone marrow transplantation

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr.  Markus   Cornberg 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Deutsche Leberstiftung
    • Ms.  Dr.  Julia   Kahlhöfer 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • DZIF (Deutsches Zentrum für Infektionsforschung)
    • Inhoffenstraße 7
    • 38124  Braunschweig
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.