Terlipressin Administration in Septic Shock Refractory to Catecholamines

November 18, 2008 updated by: Assaf-Harofeh Medical Center

Terlipressin Administration in Septic Shock Refractory to Catecholamines Bolus vs. Continuous Drip-Phase II

terlipressin is given to refractory septic shock patients who do not respond to noradrenalin in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is better to give it by continuous drip and avoid abrupt changes in BP and heart function

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

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

  • Israel
      • Zrifin, Israel, 70300
        • Asaf Harofeh MC

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • septic shock patients receiving above 0.5 mcg/kg NA

Exclusion Criteria:

  • allergy to terlipressin, CHF, IHD, pregnancy

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: terlipressin bolus
1 mg of terlipressin received one time only
Drug: terlipressin
1 mg of terlipressin one time only
Other Names:
  • glypressin
Drug: terlipressin
1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h
Experimental: terlipressin drip
Drug: terlipressin
1 mg of terlipressin one time only
Other Names:
  • glypressin
Drug: terlipressin
1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CI, SVR,HR,BP, noradrenalin administration,renal function
Time Frame: 6 mo
6 mo

Collaborators and Investigators

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

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Study Director: Tal Mann, Dr, Asaf Harofeh

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 (Anticipated)

July 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

November 18, 2008

First Submitted That Met QC Criteria

November 18, 2008

First Posted (Estimate)

November 19, 2008

Study Record Updates

Last Update Posted (Estimate)

November 19, 2008

Last Update Submitted That Met QC Criteria

November 18, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 161/08

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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