Contact information
Type
Scientific
Primary contact
Dr J J Kuiper
ORCID ID
Contact details
Erasmus Medical Centre
Department of Hepatology and Gastroenterology
Room Ca 326a
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
+31 (0)10 463 3045
j.j.kuiper@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR463
Study information
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
Acronym
TAPP-study
Study hypothesis
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
Received from the local medical ethics committee
Study design
Multicentre randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Decrease in EABV. This is an increase in plasma renin concentration (PRC) of more than 50% of baseline values 6 days after paracentesis.
Secondary outcome measures
1. Circulatory parameters
2. Renal function
3. Body weight (recurrence of ascites)
4. Adverse events
5. Costs
Overall trial start date
01/12/2005
Overall trial end date
30/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Cirrhosis with tense ascites requiring therapeutic paracentesis
2. Aged 18 - 70 years
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
84
Participant 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
Recruitment start date
01/12/2005
Recruitment end date
30/11/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands
Funders
Funder type
Research organisation
Funder name
Dutch Society for Hepatology (Nederlandse Vereniging voor Hepatologie [NVH]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation for Liver and Gastrointestinal Research (SLO) (Netherlands) - Erasmus Medical Centre
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