Trial document




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  DRKS00017567

Trial Description

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Title

Massive ascites: Fractional draining as an alternative to single paracentesis with albumin substitution

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Trial Acronym

none

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Many patients suffer from liver cirrhosis. This disease is associated with many problems. One of the problems is ascites. Ascites should be treated. The kind of treatment depends on the amount of ascites. If there is a lot of ascites, it needs to be removed. We remove the ascites slowly to avoid severe fluid shifts. Besides that patients receive infusions. This happens to avoid severe fluid shits, too. We do this because to severe fluid shifts can cause damage to the patients and lead to kidney damage and a change in composition of the blood salts.

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Brief Summary in Scientific Language

The aim of this project is to analyze an alternative method of paracentesis in patients with hydropically decompensated liver cirrhosis regarding effectiveness and safety. National and international guidelines recommend a single paracentesis. In this case the entire ascites is drained once in a short amount of time. 8 g human albumin are substituted per litre ascites if more than 5 litres are removed. This happen to prevent the so-called paracentesis circulatory dysfunction (PPCD) which implies a higher risk of hyponatremia and acute kidney failure due to massive fluid shifts.
In our project we want to investigate an alternative method of draining ascites. The ascites is not being removed suddenly but fractionally (1.5 l/8 h). To avoid distinct fluid shifts the patients receive an intravenous substitution of the drained volume with crystalloid fluid (1:3-1:2, depending on the patient's volume status).

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Organizational Data

  •   DRKS00017567
  •   2019/06/26
  •   [---]*
  •   yes
  •   Approved
  •   203_19 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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

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

  •   Day 0:
    a) Exclusion of contraindications
    b) Inclusion in study
    c) Blood withdrawal: Plasma renin concentration, sodium, potassium, creatinine, urea, blood count, Quick value, CRP, bilirubin, albumin, total protein, one additional serum tube (withdrawal is usually possible as part of the routine control)

    Day 3:
    a) See day 0 c)
    b) Collection of 24-hour urine to measure creatinine clearance, excretion of electrolytes and fractional sodium excretion

    End of the study: If no or hardly any ascites is drained any longer and it has been sonographically confirmed that there is none or only mild ascites left.
    a) See day 0 c)
    b) Measuring the cell count in the remaining ascitic fluid

    Daily: Physical examination; 2x heart rate, 2x blood pressure, 1x body weight, 1x respiratory rate, 1x temperature, pause of diuretics

    The duration of the study for each patient is as long as there is a hydropic decompensation, which requires inpatient treatment.
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Characteristics

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

Change in plasma renin concentration

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Secondary Outcome

a) Serum sodium concentration
b) Serum creatinine, Serum urea, Creatinine clearance
c) Cell count in ascites or a different sign of infection (e.g. redness of the injection site, increase of inflammatory parameters)
d) Changes in blood count

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/07/15
  •   36
  •   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

Patients with hydropically decompensated liver cirrhosis (secured by imaging or histologically) of any genesis, who are older than 18 years and able to give informed consent and whose ascites is sonographically assessed worth draining.

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Exclusion Criteria

a) Bilirubin > 10 mg/dl
b) Serum Creatinine > 3 mg/dl
c) Active bleeding
d) Spontaneous bacterial peritonitis
e) Severe infection or sepsis (according to judgment of the clinical investigator)
f) Known primary kidney disease
g) Known heart failure
- (1) if the symptoms are classified >2 according to New york heart association classification (NYHA) or ejection fraction < 35%
- (2) if NYHA >2 (mild shortness of breath and slight limitation in ordinary activity) or ejection fraction < 35%
h) Known active malignancy
i) Platelets < 40000
j) Quick value < 40%
k) Serum Sodium < 125 mmol/L
l) Pregnancy
m) Breastfeeding mothers

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Addresses

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    • Medizinische Klinik 1 des Universitätsklinikums Erlangen
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Medizinische Klinik 1 desUniversitätsklinikums Erlangen
    • Mr.  Dr. med.  André  Jefremow 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Medizinische Klinik 1 des UK Erlangen
    • Mr.  Dr. med.  André  Jefremow 
    • Ulmenweg 8
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Klinik 1 des Universitätsklinikums Erlangen
    • Mr.  Dr. med.  André  Jefremow 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.