Back to resultsContinuous Infusion of Terlipressin in Septic Shock
Primary Purpose
Septic Shock
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Terlipressin
Vasopressin
Norepinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Sepsis, Septic Shock, vasopressin, terlipressin
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Septic shock
- vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)
Exclusion Criteria:
- Pregnancy
- Present cardiac dysfunction
- Present or suspected acute mesenteric ischemia
Sites / Locations
- Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Terlipressin
Vasopressin
titrated norepinephrine
Outcomes
Primary Outcome Measures
Systemic and regional hemodynamics
Secondary Outcome Measures
Markers of inflammation,organ functions,adverse effects.
Full Information
NCT ID
NCT00481572
First Posted
May 30, 2007
Last Updated
February 26, 2008
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT00481572
Brief Title
Continuous Infusion of Terlipressin in Septic Shock
Official Title
Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. "THE TERLIVAP STUDY"
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether: A)the continuous infusion ultra-low dose of terlipressin (1.3 micrograms/kg/h) is able to stabilize hemodynamic in patients with septic shock, reducing the risk of adverse effects related to the bolus dose.B)the continuous infusion ultra-low dose of terlipressin may be use in lieu of vasopressin.
Detailed Description
Forty-five septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation were enrolled in the study. Patients were randomly allocated to be treated with either a) a continuous terlipressin infusion (1.3 µg•kg-1), b) vasopressin (0.03 U•min-1), or c) titrated norepinephrine (control; each n = 15). In both the terlipressin and vasopressin group, norepinephrine was additionally administered to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, cytokines concentrations, were obtained at baseline and after 12, 24, 36 and 48 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Sepsis, Septic Shock, vasopressin, terlipressin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Terlipressin
Arm Title
2
Arm Type
Experimental
Arm Description
Vasopressin
Arm Title
3
Arm Type
Active Comparator
Arm Description
titrated norepinephrine
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Intervention Description
continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Intervention Description
continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
titrated norepinephrine over a period of 48 hrs
Primary Outcome Measure Information:
Title
Systemic and regional hemodynamics
Time Frame
during the first 48 hours from the onset of septic shock
Secondary Outcome Measure Information:
Title
Markers of inflammation,organ functions,adverse effects.
Time Frame
during the first 48 hours from the onset of septic shock
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Septic shock
vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)
Exclusion Criteria:
Pregnancy
Present cardiac dysfunction
Present or suspected acute mesenteric ischemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Morelli, MD
Organizational Affiliation
Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
City
Rome, Viale del Policlinico 155
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19664253
Citation
Morelli A, Ertmer C, Rehberg S, Lange M, Orecchioni A, Cecchini V, Bachetoni A, D'Alessandro M, Van Aken H, Pietropaoli P, Westphal M. Continuous terlipressin versus vasopressin infusion in septic shock (TERLIVAP): a randomized, controlled pilot study. Crit Care. 2009;13(4):R130. doi: 10.1186/cc7990. Epub 2009 Aug 10.
Results Reference
derived
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Continuous Infusion of Terlipressin in Septic Shock
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