Condition category
Digestive System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
16/04/2009
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

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

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes