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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Roma La Sapienza

Additional 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
Study First Received: May 30, 2007
Last Updated: February 26, 2008
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 16, 2014