Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT03027635
Eligibility Criteria:
Inclusion Criteria:
* Cirrhosis of any aetiology
* Diuretic resistant ascites defined as i) an inability to mobilise ascites (minimal or no weight loss) despite administration with the maximum tolerable doses of oral diuretics or a daily dose of spironolactone 400 mg and re-accumulation of fluid after therapeutic paracentesis within two weeks or ii) diuretic-related complications including (but not limited to) azotemia, hepatic encephalopathy, or progressive electrolyte imbalances
* Able to read and understand Danish
* Signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female of any age
* Age at least 18 years
* Expected survival at least three months.
Exclusion Criteria:
* Participants eligible and listed for TIPS
* Serum creatinine levels above 135 umol/L
* Overt hepatic encephalopathy in the two weeks before randomization
* Ascites due to other causes than cirrhosis such as: malignant disease, congestive heart failure, end-stage renal disease, pancreatitis, or Budd-Chiari (hepatic vein thrombosis), or chylous ascites
* Ongoing intra-abdominal infection (peritonitis) or active systemic or local infections, such as urinary tract infection or pneumonia
* Participation in a clinical study that may interfere with participation in this study;
* Evidence of extensive ascites loculation
* Coagulopathy
* Variceal bleeding within two weeks before randomisation
* Intraabdominal surgery within four months before randomisation
* Spontaneous bacterial peritonitis (neutrophil count\>250/µl within 24 hours of randomization)
* Patients with an increased risk of procedure related complications as judged by the primary healthcare provider
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03027635
Study Brief:
Protocol Section:
NCT03027635