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Continuous Infusion of Terlipressin in Septic Shock

NCT ID: NCT00481572

Last Updated: 2008-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Septic Shock

Keywords

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Sepsis Septic Shock vasopressin terlipressin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Terlipressin

Group Type EXPERIMENTAL

Terlipressin

Intervention Type DRUG

continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs

2

Vasopressin

Group Type EXPERIMENTAL

Vasopressin

Intervention Type DRUG

continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs

3

titrated norepinephrine

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

titrated norepinephrine over a period of 48 hrs

Interventions

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Terlipressin

continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs

Intervention Type DRUG

Vasopressin

continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs

Intervention Type DRUG

Norepinephrine

titrated norepinephrine over a period of 48 hrs

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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University of Roma "La Sapienza"

Principal Investigators

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Andrea Morelli, MD

Role: STUDY_DIRECTOR

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

Locations

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Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"

Rome, Viale Del Policlinico 155, , Italy

Site Status

Countries

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Italy

References

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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. doi: 10.1186/cc7990. Epub 2009 Aug 10.

Reference Type DERIVED
PMID: 19664253 (View on PubMed)

Other Identifiers

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1124

Identifier Type: -

Identifier Source: org_study_id