Continuous Infusion of Terlipressin in Septic Shock

This study has been completed.

Sponsor:

Information provided by:

University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT00481572

First received: May 30, 2007

Last updated: February 26, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 30, 2007

Last Updated Date

February 26, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Systemic and regional hemodynamics [ Time Frame: during the first 48 hours from the onset of septic shock ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Systemic and regional hemodynamics [ Time Frame: during the first 48 hours from the onset of septic shock ]

Change History

Complete list of historical versions of study NCT00481572 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Markers of inflammation,organ functions,adverse effects. [ Time Frame: during the first 48 hours from the onset of septic shock ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Markers of inflammation,organ functions,adverse effects. [ Time Frame: during the first 48 hours from the onset of septic shock ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Continuous Infusion of Terlipressin in Septic Shock

Official Title ^ICMJE

Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. "THE TERLIVAP STUDY"

Brief Summary

The purpose of this study is to determine whether: A)the continuous infusion ultra-low dose of terlipressin (1.3 micrograms/kg/h) is able to stabilize hemodynamic in patients with septic shock, reducing the risk of adverse effects related to the bolus dose.B)the continuous infusion ultra-low dose of terlipressin may be use in lieu of vasopressin.

Detailed Description

Forty-five septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation were enrolled in the study. Patients were randomly allocated to be treated with either a) a continuous terlipressin infusion (1.3 µg•kg-1), b) vasopressin (0.03 U•min-1), or c) titrated norepinephrine (control; each n = 15). In both the terlipressin and vasopressin group, norepinephrine was additionally administered to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, cytokines concentrations, were obtained at baseline and after 12, 24, 36 and 48 hours.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Septic Shock

Intervention ^ICMJE

Drug: Terlipressin
continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs
Drug: Vasopressin
continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs
Drug: Norepinephrine
titrated norepinephrine over a period of 48 hrs

Study Arm (s)

Experimental: 1
Terlipressin

Intervention: Drug: Terlipressin
Experimental: 2
Vasopressin

Intervention: Drug: Vasopressin
Active Comparator: 3
titrated norepinephrine

Intervention: Drug: Norepinephrine

Publications *

Morelli A, Ertmer C, Rehberg S, Lange M, Orecchioni A, Cecchini V, Bachetoni A, D'Alessandro M, Van Aken H, Pietropaoli P, Westphal M. Continuous terlipressin versus vasopressin infusion in septic shock (TERLIVAP): a randomized, controlled pilot study. Crit Care. 2009;13(4):R130. Epub 2009 Aug 10.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of Septic shock
vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion Criteria:

Pregnancy
Present cardiac dysfunction
Present or suspected acute mesenteric ischemia

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00481572

Other Study ID Numbers ^ICMJE

1124

Has Data Monitoring Committee

Responsible Party

Andrea Morelli, University of Roma "La Sapienza"

Study Sponsor ^ICMJE

University of Roma La Sapienza

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Andrea Morelli, MD

Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"

Information Provided By

University of Roma La Sapienza

Verification Date

February 2008

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

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