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

Recruiting

Conditions: R18
K74
Ascites
Fibrosis and cirrhosis of liver

Registration Number: DRKS00017567

Lead Sponsor: Medizinische Klinik 1 des Universitätsklinikums Erlangen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 36

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.

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in plasma renin concentration

Secondary Outcome Measures

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