Condition category
Digestive System
Date applied
22/11/2006
Date assigned
03/01/2007
Last edited
03/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hendrik Vilstrup

ORCID ID

Contact details

Department of Medicine V
Aarhus University Hospital
Aarhus
8200
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Urodilatin is able to induce natriuresis and diuresis in liver cirrhosis patients with severe sodium retention.

Ethics approval

Approval received from local ethics committee (Den Videnskabsetiske Komité for Aarhus Amt), date of approval: 29 September 1998 (reference number: 1998/4274).

Study design

Randomised single-blind placebo-controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Urodilatin

Primary outcome measures

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 trial start date

28/01/1999

Overall trial end date

01/02/2001

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

15

Participant 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

Recruitment start date

28/01/1999

Recruitment end date

01/02/2001

Locations

Countries of recruitment

Denmark

Trial participating centre

Department of Medicine V
Aarhus
8200
Denmark

Sponsor information

Organisation

Aarhus University Hospital (Denmark)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.sundhed.dk/wps/portal/_s.155/1921?_ARTIKELGRUPPE_ID_=1044040715102806

Funders

Funder type

Other

Funder name

This is an investigator driven and funded trial.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes