The natriuretic and diuretic effects of urodilatin in cirrhosis patients with severe sodium retention
| ISRCTN | ISRCTN36020026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36020026 |
| Protocol serial number | N/A |
| Sponsor | Aarhus University Hospital (Denmark) |
| Funder | This is an investigator driven and funded trial. |
- Submission date
- 22/11/2006
- Registration date
- 03/01/2007
- Last edited
- 14/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hendrik Vilstrup
Scientific
Scientific
Department of Medicine V
Aarhus University Hospital
Aarhus
8200
Denmark
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-blind placebo-controlled cross-over study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Urodilatin |
| Primary outcome measure(s) |
The renal effects of Urodilatin were investigated in a clearance study. Primary outcomes were: |
| Key secondary outcome measure(s) |
1. Systemic blood pressure |
| Completion date | 01/02/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Medicine V
Aarhus
8200
Denmark
8200
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2007 | 14/01/2021 | Yes | No |
Editorial Notes
14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
