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

Cirrhosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00742690
• Other study ID #: 1442P
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 26, 2008
• Last updated: October 11, 2014
• Start date: May 2005
• Est. completion date: March 2015

Study information

• Verified date: October 2014
• Source: University of Padova
• Contact: Alessandra Galioto, MD
• Email: alegalioto[@]unipd.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Hepatorenal Syndrome
• Liver Cirrhosis
• Syndrome
• Type 1 Hepatorenal Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Liver Unit, General Hospital	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 wi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end-point of the study is the complete reform of the renal function (creatinine < 1.5 mg/dl).		The treatment will be continued for a maximum of 15 days	Yes