Terlipressin versus albumin in the prevention of paracentesis-associated adverse events in patients with cirrhosis and tense ascites
| ISRCTN | ISRCTN36383299 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36383299 |
| Protocol serial number | NTR463 |
| Sponsor | Foundation for Liver and Gastrointestinal Research (SLO) (Netherlands) |
| Funders | Dutch Society for Hepatology (Nederlandse Vereniging voor Hepatologie [NVH]) (Netherlands), Foundation for Liver and Gastrointestinal Research (SLO) (Netherlands) - Erasmus Medical Centre |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 16/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J J Kuiper
Scientific
Scientific
Erasmus Medical Centre
Department of Hepatology and Gastroenterology
Room Ca 326a
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
| Phone | +31 (0)10 463 3045 |
|---|---|
| j.j.kuiper@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Terlipressin versus albumin in the prevention of paracentesis associated adverse events in patients with cirrhosis and tense ascites: a multicentre randomised controlled trial |
| Study acronym | TAPP-study |
| Study objectives | The effect of terlipressin on the effective arterial blood volume (EABV) in patients with cirrhosis and (tense) ascites who receive a therapeutic paracentesis, is equivalent to the current standard treatment with human albumin without the risks of a blood product and with lower costs. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Cirrhosis of the liver/ascites |
| Intervention | Patients will be randomly assigned to receive either terlipressin or albumin, the standard treatment, intravenously (iv) when they receive a therapeutic paracentesis. The terlipressin group will receive an iv-bolus of 1 mg terlipressin at onset of therapeutic paracentesis and another iv-bolus of 2 mg 6 hours after paracentesis. The albumin group will receive 8 g of albumin iv per litre of ascitic fluid removed. At onset, after 6 hours, and on day 6 after paracentesis vital functions, blood, urine, and ascitic fluid samples will be taken to measure the effect of the medication. |
| Intervention type | Other |
| Primary outcome measure(s) | Decrease in EABV. This is an increase in plasma renin concentration (PRC) of more than 50% of baseline values 6 days after paracentesis. |
| Key secondary outcome measure(s) | 1. Circulatory parameters 2. Renal function 3. Body weight (recurrence of ascites) 4. Adverse events 5. Costs |
| Completion date | 30/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 84 |
| Key inclusion criteria | 1. Cirrhosis with tense ascites requiring therapeutic paracentesis 2. Aged 18 - 70 years 3. Written informed consent |
| Key exclusion criteria | 1. Hypertension treated with medication 2. History of cardiac or coronary disease 3. Circulatory unstable 4. Until 5 days prior to paracentesis: 4.1. Infusion of a plasma expander 4.2. Gastro-intestinal haemorrhage 4.3. Spontaneous bacterial peritonitis 5. Systemic administration of antibiotics within the past 14 days for a period of more than 24 hours, with the exception of quinolones 6. Hepatocellular carcinoma 7. Hepatic encephalopathy 8. Pregnancy or lack of adequate contraception in sexually active females 9. Any other condition which in the opinion of the investigator would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the study |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 30/11/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands
3015 GD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
