The natriuretic and diuretic effects of urodilatin in cirrhosis patients with severe sodium retention

ISRCTN	ISRCTN36020026
DOI	https://doi.org/10.1186/ISRCTN36020026
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Hendrik Vilstrup
Scientific

Department of Medicine V
Aarhus University Hospital
Aarhus
8200
Denmark

Study design	Randomised single-blind placebo-controlled cross-over study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	The natriuretic and diuretic effects of urodilatin in cirrhosis patients with severe sodium retention
Study objectives	Urodilatin is able to induce natriuresis and diuresis in liver cirrhosis patients with severe sodium retention.
Ethics approval(s)	Approval received from local ethics committee (Den Videnskabsetiske Komité for Aarhus Amt), date of approval: 29 September 1998 (reference number: 1998/4274).
Health condition(s) or problem(s) studied	Decompensated liver cirrhosis.
Intervention	Comparison of 90 minutes intravenous (i.v.) infusion of synthetic urodilatin with placebo: 1. Urodilatin was dissolved in isotonic saline and the infusion dose was 20 ng/kg/min. Infusion rate was 0.27 mL/kg/hour 2. Placebo was isotonic saline
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Urodilatin
Primary outcome measure	The renal effects of Urodilatin were investigated in a clearance study. Primary outcomes were: 1. Urine flow rate 2. Urine sodium excretion rate 3. Plasma cyclic Guanosine 3',5'-MonoPhosphate (GMP)
Secondary outcome measures	1. Systemic blood pressure 2. The plasma hormones renin, angiotensin II and aldosterone
Overall study start date	28/01/1999
Completion date	01/02/2001

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	15
Total final enrolment	7
Key inclusion criteria	1. Presence of cirrhosis in a liver biopsy 2. Anamnestic, clinical and laboratory evidence of cirrhosis including ascites (verified by ultrasound), oesophagogastric varices (verified by gastroscopy), hypoalbuminemia and reduced prothrombin index 3. A 24 hour urine sodium excretion less than 60 mmol 4. Written informed consent
Key exclusion criteria	1. Primary kidney disease (s-creatinine more than 200 mmol/L) 2. Congestive heart failure 3. Diabetes 4. Haemoglobin less than 6.0 mmol/L 5. A history of bladder dysfunction
Date of first enrolment	28/01/1999
Date of final enrolment	01/02/2001

Department of Medicine V

Aarhus
8200
Denmark

Aarhus University Hospital (Denmark)
Hospital/treatment centre

c/o Prof. Hendrik Vilstrup MD
Department of Medicine V
Aarhus
DK-8200
Denmark

Website	http://www.sundhed.dk/wps/portal/_s.155/1921?_ARTIKELGRUPPE_ID_=1044040715102806
"ROR"	https://ror.org/040r8fr65

Other

This is an investigator driven and funded trial.

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2007	14/01/2021	Yes	No

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.