Continuous Infusion of Terlipressin in Septic Shock

This study has been completed.
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00481572
First received: May 30, 2007
Last updated: February 26, 2008
Last verified: February 2008

May 30, 2007
February 26, 2008
January 2007
December 2007   (final data collection date for primary outcome measure)
Systemic and regional hemodynamics [ Time Frame: during the first 48 hours from the onset of septic shock ] [ Designated as safety issue: Yes ]
Systemic and regional hemodynamics [ Time Frame: during the first 48 hours from the onset of septic shock ]
Complete list of historical versions of study NCT00481572 on ClinicalTrials.gov Archive Site
Markers of inflammation,organ functions,adverse effects. [ Time Frame: during the first 48 hours from the onset of septic shock ] [ Designated as safety issue: Yes ]
Markers of inflammation,organ functions,adverse effects. [ Time Frame: during the first 48 hours from the onset of septic shock ]
Not Provided
Not Provided
 
Continuous Infusion of Terlipressin in Septic Shock
Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. "THE TERLIVAP STUDY"

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Septic Shock
  • Drug: Terlipressin
    continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs
  • Drug: Vasopressin
    continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs
  • Drug: Norepinephrine
    titrated norepinephrine over a period of 48 hrs
  • Experimental: 1
    Terlipressin
    Intervention: Drug: Terlipressin
  • Experimental: 2
    Vasopressin
    Intervention: Drug: Vasopressin
  • Active Comparator: 3
    titrated norepinephrine
    Intervention: Drug: Norepinephrine
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. Epub 2009 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00481572
1124
No
Andrea Morelli, University of Roma "La Sapienza"
University of Roma La Sapienza
Not Provided
Study Director: Andrea Morelli, MD Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
University of Roma La Sapienza
February 2008

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