Back to resultsTerlipressin Administration in Septic Shock Refractory to Catecholamines
Primary Purpose
Septic Shock
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
terlipressin
terlipressin
Sponsored by
About this trial
This is an interventional supportive care trial for Septic Shock focused on measuring septic shock refractory to catecholamines
Eligibility Criteria
Inclusion Criteria:
- septic shock patients receiving above 0.5 mcg/kg NA
Exclusion Criteria:
- allergy to terlipressin, CHF, IHD, pregnancy
Sites / Locations
- Asaf Harofeh MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
terlipressin bolus
terlipressin drip
Arm Description
1 mg of terlipressin received one time only
Outcomes
Primary Outcome Measures
CI, SVR,HR,BP, noradrenalin administration,renal function
Secondary Outcome Measures
Full Information
NCT ID
NCT00793559
First Posted
November 18, 2008
Last Updated
November 18, 2008
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00793559
Brief Title
Terlipressin Administration in Septic Shock Refractory to Catecholamines
Official Title
Terlipressin Administration in Septic Shock Refractory to Catecholamines Bolus vs. Continuous Drip-Phase II
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock refractory to catecholamines
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
terlipressin bolus
Arm Type
Active Comparator
Arm Description
1 mg of terlipressin received one time only
Arm Title
terlipressin drip
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
terlipressin
Other Intervention Name(s)
glypressin
Intervention Description
1 mg of terlipressin one time only
Intervention Type
Drug
Intervention Name(s)
terlipressin
Intervention Description
1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h
Primary Outcome Measure Information:
Title
CI, SVR,HR,BP, noradrenalin administration,renal function
Time Frame
6 mo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
septic shock patients receiving above 0.5 mcg/kg NA
Exclusion Criteria:
allergy to terlipressin, CHF, IHD, pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tal Mann, Dr
Phone
97257345789
Email
tal_mb@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tal Mann, Dr
Organizational Affiliation
Asaf Harofeh
Official's Role
Study Director
Facility Information:
Facility Name
Asaf Harofeh MC
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Terlipressin Administration in Septic Shock Refractory to Catecholamines
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