R18 K74
Conditions
Interventions
Group 1: 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, bilirubi
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,
Sponsors
Medizinische Klinik 1 des Universitätsklinikums Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in plasma renin concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactAndré Jefremow
Medizinische Klinik 1 des UK Erlangen
Outcome results
None listed