NCT00370253

Brief Summary

The purpose of this study is to determine whether noradrenalin is as effective and safe as terlipressin in the treatment of hepatorenal syndrome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

1 year

First QC Date

August 30, 2006

Last Update Submit

April 9, 2008

Conditions

Hepatorenal Syndrome

Keywords

hepatorenal syndromeascitesportal hypertensioncirrhosis

Outcome Measures

Primary Outcomes (1)

  • Renal function at the beginning and at the end of therapy

    two weeks

Secondary Outcomes (1)

  • Circulatory function

    two weeks

Study Arms (2)

2

ACTIVE COMPARATOR

Terlipressin

Drug: Terlipressin

1

EXPERIMENTAL

Noradrenalin

Drug: Noradrenalin

Interventions

TerlipressinDRUG

1mg/4 h per day

2
NoradrenalinDRUG

0,1 mcg/kg/min

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hepatorenal syndrome
  • Age: 18-75 years
  • Informed written consent

You may not qualify if:

  • Multinodular hepatocellular carcinoma (more than 3 nodules)
  • Portal vein thrombosis
  • Ongoing bacterial infection
  • Ongoing or recent (less than one week) bleeding
  • Cardio-pulmonary failure
  • Coronary artery disease
  • Peripheral artery disease
  • Arterial hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni Battista Hospital

Turin, 10126, Italy

Location

Related Publications (3)

  • Ortega R, Gines P, Uriz J, Cardenas A, Calahorra B, De Las Heras D, Guevara M, Bataller R, Jimenez W, Arroyo V, Rodes J. Terlipressin therapy with and without albumin for patients with hepatorenal syndrome: results of a prospective, nonrandomized study. Hepatology. 2002 Oct;36(4 Pt 1):941-8. doi: 10.1053/jhep.2002.35819.

    PMID: 12297842BACKGROUND

  • Duvoux C, Zanditenas D, Hezode C, Chauvat A, Monin JL, Roudot-Thoraval F, Mallat A, Dhumeaux D. Effects of noradrenalin and albumin in patients with type I hepatorenal syndrome: a pilot study. Hepatology. 2002 Aug;36(2):374-80. doi: 10.1053/jhep.2002.34343.

    PMID: 12143045BACKGROUND

  • Alessandria C, Ottobrelli A, Debernardi-Venon W, Todros L, Cerenzia MT, Martini S, Balzola F, Morgando A, Rizzetto M, Marzano A. Noradrenalin vs terlipressin in patients with hepatorenal syndrome: a prospective, randomized, unblinded, pilot study. J Hepatol. 2007 Oct;47(4):499-505. doi: 10.1016/j.jhep.2007.04.010. Epub 2007 May 24.

    PMID: 17560680DERIVED

MeSH Terms

Conditions

Hepatorenal SyndromeAscitesHypertension, PortalFibrosis

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Mario Rizzetto, MD

    Division of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

April 11, 2008

Record last verified: 2008-04

Locations

IT(1)