Terlipressin Given As I.V. Boluses Versus Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Padova.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT00742690
First received: August 26, 2008
Last updated: August 4, 2011
Last verified: August 2011

August 26, 2008
August 4, 2011
May 2005
December 2011   (final data collection date for primary outcome measure)
The primary end-point of the study is the complete reform of the renal function (creatinine < 1.5 mg/dl). [ Time Frame: The treatment will be continued for a maximum of 15 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00742690 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Terlipressin Given As I.V. Boluses Versus Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome
Terlipressin Given As I.V. Boluses Vs Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome (Hrs): Preliminary Results Of A Randomized Controlled Clinical Study.

It is well known that terlipressin and albumin improve renal function in patients with cirrhosis and type 1 HRS. In previous studies terlipressin has been used either as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr or as continuous intravenous infusion at the initial dose of 2 mg/24 h. Up to now the two schedules of i.v. administration of terlipressin have never been compared. Nevertheless, it has been hypothesized that continuous intravenous infusion assures a more steady profile of effect on portal pressure in patients with cirrhosis. Thus, the aim of the study will be to compare terlipressin given as i.v. bolus vs terlipressin given as continuous intravenous infusion in the treatment of type 1 HRS in patients with cirrhosis.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cirrhosis
  • Type 1 Hepatorenal Syndrome
  • Drug: terlipressin given by intravenous boluses and albumin
    Patients who will be randomly assigned to arm 1 will received terlipressin given by intravenous boluses at the initial dose of terlipressin was 0.5 mg/4 hr. In case of non response, the dose of terlipressin was progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given intravenously at the dose of 1 g/kg of body weight on the first day followed by 20-40 g/day.
  • Drug: terlipressin given by continuous intravenous infusion and albumin
    Patients who will be randomly assigned to arm 1 will received terlipressin given as intravenous boluses at the initial dose of 0.5 mg/4 hr. In case of non response, the dose of terlipressin will be progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given at the dose of 1 g/kg of body weight at the first day followed by 20-40 g/day.
  • Active Comparator: 1
    35 patients with cirrhosis and type 1 HRS
    Intervention: Drug: terlipressin given by intravenous boluses and albumin
  • Experimental: 2
    35 patients with cirrhosis and type 1 HRS
    Intervention: Drug: terlipressin given by continuous intravenous infusion and albumin
Angeli P, Guarda S, Fasolato S, Miola E, Craighero R, Piccolo F, Antona C, Brollo L, Franchin M, Cillo U, Merkel C, Gatta A. Switch therapy with ciprofloxacin vs. intravenous ceftazidime in the treatment of spontaneous bacterial peritonitis in patients with cirrhosis: similar efficacy at lower cost. Aliment Pharmacol Ther. 2006 Jan 1;23(1):75-84.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
March 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with cirrhosis and type 1 HRS

Exclusion Criteria:

  • HCC beyond the Milan Criteria,septic shock (systolic arterial pressure < 90 mmHg,
  • Significant heart or respiratory failure,
  • Peripheral arteriophaty clinically significant,
  • Previous heart stroke or significant alteration of the ECG
Both
18 Years to 75 Years
No
Contact: Alessandra Galioto, MD alegalioto@unipd.it
Italy
 
NCT00742690
1442P
No
Clinica Medica 5, Univeristy of Padova
University of Padova
Not Provided
Not Provided
University of Padova
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP