Terlipressin in Septic Shock: Effects on Microcirculation

February 3, 2010 updated by: University of Roma La Sapienza

Vasopressin Receptor Agonists in Septic Shock: Effects on Microcirculation

The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

60 septic shock patients requiring norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. After an initial hemodynamic resuscitation aimed at achieve a mean arterial pressure between 65 and 75 mmHg and normovolemia, patients will be randomly allocated to be treated with either a) intravenous administration of terlipressin 1 µg∙kg-1∙h-1 for 6 hrs, b) intravenous administration of arginine vasopressin 0.04 UI∙min-1 for 6 hrs, c) intravenous administration of terlipressin bolus dose of 0.5 mg (each n = 20). In all groups open label norepinephrine will be additionally administered to maintain a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization and sublingual microvascular network will be obtained just before randomization (baseline) and then after 6 hours in the vasopressin, terlipressin infusion and terlipressin bolus groups.

The sublingual microvascular network will be studied using the sidestream dark field (SDF)imaging. The device will be applied on the lateral side of the tongue, in an area approximately 2-4 cm from the tip of the tongue. Sequences of 10 secs from eight adjacent areas will be recorded on disk using a personal computer. These sequences will be later analyzed by an investigator blinded to the patient's diagnosis and therapy.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • I
      • Rome, I, Italy, 00161
        • Departement of Anesthesiology and Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Age < 18 years
  • Present or suspected acute mesenteric ischemia
  • Vasospastic diathesis (e.g. Raynaud's syndrome or related diseases)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: continuous terlipressin
Drug: continuous infusion of terlipressin
Intravenous continuous infusion of terlipressin 1 µg•kg-1•h-1 for 6 hrs
Experimental: vasopressin
Drug: Arginine vasopressin
Intravenous continuous infusion of arginine vasopressin 0.04 UI•min-1 for 6 hrs
Experimental: terlipressin bolus dose
Drug: terlipressin bolus administration
intravenous terlipressin bolus administration at the dose of 0.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)
Time Frame: over a period of 6 hrs from the time of randomization
over a period of 6 hrs from the time of randomization
Oxygen transport variables
Time Frame: over a period of 6 from the time of randomization
over a period of 6 from the time of randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Acid-base homeostasis
Time Frame: over a period of 6 hrs from the time of randomization
over a period of 6 hrs from the time of randomization
Functional capillary density (mm/mm2) (FCD)
Time Frame: over a period of 6 hrs from the time of randomization
over a period of 6 hrs from the time of randomization
De Backer score
Time Frame: over a period of 6 hrs from the time of randomization
over a period of 6 hrs from the time of randomization
Perfused Vessel Density (PVD) (mm/mm2)
Time Frame: over a period of 6 hrs from the time of randomization
over a period of 6 hrs from the time of randomization
Proportion of Perfused vessels (%) (PPV)
Time Frame: over a period of 6 hrs from the time of randomization
over a period of 6 hrs from the time of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Andrea Morelli, MD, University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 14, 2009

First Posted (Estimate)

October 15, 2009

Study Record Updates

Last Update Posted (Estimate)

February 4, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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