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
Secondary identifying numbers NTR463
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

Erasmus Medical Centre
Department of Hepatology and Gastroenterology
Room Ca 326a
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Phone +31 (0)10 463 3045
Email j.j.kuiper@erasmusmc.nl

Study information

Study designMulticentre randomised active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleTerlipressin versus albumin in the prevention of paracentesis associated adverse events in patients with cirrhosis and tense ascites: a multicentre randomised controlled trial
Study acronymTAPP-study
Study objectivesThe 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) studiedCirrhosis of the liver/ascites
InterventionPatients 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 typeOther
Primary outcome measureDecrease in EABV. This is an increase in plasma renin concentration (PRC) of more than 50% of baseline values 6 days after paracentesis.
Secondary outcome measures1. Circulatory parameters
2. Renal function
3. Body weight (recurrence of ascites)
4. Adverse events
5. Costs
Overall study start date01/12/2005
Completion date30/11/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants84
Key inclusion criteria1. Cirrhosis with tense ascites requiring therapeutic paracentesis
2. Aged 18 - 70 years
3. Written informed consent
Key exclusion criteria1. 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 enrolment01/12/2005
Date of final enrolment30/11/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands

Sponsor information

Foundation for Liver and Gastrointestinal Research (SLO) (Netherlands)
Research organisation

c/o Erasmus Medical Centre
Department of Hepatology and Gastroenterology
Room Ca 326
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands

ROR logo "ROR" https://ror.org/04hzejq44

Funders

Funder type

Research organisation

Dutch Society for Hepatology (Nederlandse Vereniging voor Hepatologie [NVH]) (Netherlands)

No information available

Foundation for Liver and Gastrointestinal Research (SLO) (Netherlands) - Erasmus Medical Centre

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan