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NCT00793559 Clinical Trial

Terlipressin Administration in Septic Shock Refractory to Catecholamines

Septic Shock Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00793559
Other study ID # 161/08
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received November 18, 2008
Last updated November 18, 2008
Start date November 2008
Est. completion date July 2009

Study information
Verified date November 2008
Source Assaf-Harofeh Medical Center
Contact Tal Mann, Dr
Phone 97257345789
Email tal_mb@hotmail.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- septic shock patients receiving above 0.5 mcg/kg NA

Exclusion Criteria:

- allergy to terlipressin, CHF, IHD, pregnancy

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• terlipressin
1 mg of terlipressin one time only
• terlipressin
1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h

Locations
Country Name City State
Israel Asaf Harofeh MC Zrifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary CI, SVR,HR,BP, noradrenalin administration,renal function 6 mo Yes
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