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

Tracking Information

First Received Date ^ICMJE

November 18, 2008

Last Updated Date

November 18, 2008

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CI, SVR,HR,BP, noradrenalin administration,renal function [ Time Frame: 6 mo ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Terlipressin Administration in Septic Shock Refractory to Catecholamines

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Septic Shock

Intervention ^ICMJE

Drug: terlipressin
1 mg of terlipressin one time only

Other Name: glypressin
Drug: terlipressin
1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h

Study Arm (s)

Active Comparator: terlipressin bolus
1 mg of terlipressin received one time only

Intervention: Drug: terlipressin
Experimental: terlipressin drip
Intervention: Drug: terlipressin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

septic shock patients receiving above 0.5 mcg/kg NA

Exclusion Criteria:

allergy to terlipressin, CHF, IHD, pregnancy

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Tal Mann, Dr

97257345789

tal_mb@hotmail.com

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00793559

Other Study ID Numbers ^ICMJE

161/08

Has Data Monitoring Committee

Responsible Party

Dr Yuval Leonov, Assaf-Harofeh Medical Center

Study Sponsor ^ICMJE

Assaf-Harofeh Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Tal Mann, Dr

Asaf Harofeh

Information Provided By

Assaf-Harofeh Medical Center

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top