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Terlipressin Administration in Septic Shock Refractory to Catecholamines

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ClinicalTrials.gov Identifier: NCT00793559
Recruitment Status : Unknown
Verified November 2008 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 19, 2008
Last Update Posted : November 19, 2008
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Septic Shock Drug: terlipressin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : November 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arms and Interventions
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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 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


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

Eligibility Criteria
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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
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: November 19, 2008    Key Record Dates
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