Terlipressin Administration in Septic Shock Refractory to Catecholamines

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2008 by Assaf-Harofeh Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Assaf-Harofeh Medical Center

ClinicalTrials.gov Identifier:

NCT00793559

First received: November 18, 2008

Last updated: NA

Last verified: November 2008

History: No changes posted

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Shock

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]


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


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	November 18, 2008
Last Updated:	November 18, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Assaf-Harofeh Medical Center:


septic shock refractory to catecholamines

Additional relevant MeSH terms:


Shock, Septic Shock 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

ClinicalTrials.gov processed this record on September 26, 2016

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