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:


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
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

No publications provided

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
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Terlipressin
Lypressin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Hemostatics
Coagulants
Hematologic Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014