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Continuous Infusion of Terlipressin in Septic Shock

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00481572
First Posted: June 1, 2007
Last Update Posted: February 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Roma La Sapienza
  Purpose
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.

Condition Intervention Phase
Septic Shock Drug: Terlipressin Drug: Vasopressin Drug: Norepinephrine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. "THE TERLIVAP STUDY"

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Systemic and regional hemodynamics [ Time Frame: during the first 48 hours from the onset of septic shock ]

Secondary Outcome Measures:
  • Markers of inflammation,organ functions,adverse effects. [ Time Frame: during the first 48 hours from the onset of septic shock ]

Enrollment: 45
Study Start Date: January 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Terlipressin
Drug: Terlipressin
continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs
Experimental: 2
Vasopressin
Drug: Vasopressin
continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs
Active Comparator: 3
titrated norepinephrine
Drug: Norepinephrine
titrated norepinephrine over a period of 48 hrs

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481572


Locations
Italy
Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
Rome, Viale del Policlinico 155, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Director: Andrea Morelli, MD Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Morelli, University of Roma "La Sapienza"
ClinicalTrials.gov Identifier: NCT00481572     History of Changes
Other Study ID Numbers: 1124
First Submitted: May 30, 2007
First Posted: June 1, 2007
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by University of Roma La Sapienza:
Sepsis
Septic Shock
vasopressin
terlipressin

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Terlipressin
Vasopressins
Arginine Vasopressin
Lypressin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Antihypertensive Agents