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Terlipressin Administration in Septic Shock Refractory to Catecholamines

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00793559
First Posted: November 19, 2008
Last Update Posted: November 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose
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

Condition Intervention Phase
Septic Shock Drug: terlipressin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Terlipressin Administration in Septic Shock Refractory to Catecholamines Bolus vs. Continuous Drip-Phase II

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • CI, SVR,HR,BP, noradrenalin administration,renal function [ Time Frame: 6 mo ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: terlipressin bolus
1 mg of terlipressin received one time only
Drug: terlipressin
1 mg of terlipressin one time only
Other Name: glypressin
Experimental: terlipressin drip Drug: terlipressin
1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • septic shock patients receiving above 0.5 mcg/kg NA

Exclusion Criteria:

  • allergy to terlipressin, CHF, IHD, pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793559


Contacts
Contact: Tal Mann, Dr 97257345789 tal_mb@hotmail.com

Locations
Israel
Asaf Harofeh MC Not yet recruiting
Zrifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Director: Tal Mann, Dr Asaf Harofeh
  More Information

Responsible Party: Dr Yuval Leonov, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00793559     History of Changes
Other Study ID Numbers: 161/08
First Submitted: November 18, 2008
First Posted: November 19, 2008
Last Update Posted: November 19, 2008
Last Verified: November 2008

Keywords provided by Assaf-Harofeh Medical Center:
septic shock refractory to catecholamines

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Terlipressin
Lypressin
Antihypertensive Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs