Continuous Infusion of Terlipressin in Septic Shock - Full Text View

Sponsored by:	University of Roma La Sapienza
Information provided by:	University of Roma La Sapienza
ClinicalTrials.gov Identifier:	NCT00481572

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 II

Drug Information available for: Norepinephrine Norepinephrine bitartrate Argipressin Vasopressins Terlipressin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. "THE TERLIVAP STUDY"

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
1: Experimental Terlipressin	Drug: Terlipressin continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs
2: Experimental Vasopressin	Drug: Vasopressin continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs
3: Active Comparator 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

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

Responsible Party:	University of Roma "La Sapienza" ( Andrea Morelli )
Study ID Numbers:	1124
Study First Received:	May 30, 2007
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00481572
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:

Sepsis
Septic Shock
vasopressin
terlipressin

Study placed in the following topic categories:

Arginine Vasopressin
Systemic Inflammatory Response Syndrome
Sepsis
Shock
Norepinephrine

Terlipressin
Shock, Septic
Vasopressins
Inflammation

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Coagulants
Sympathomimetics
Hematologic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Infection

Adrenergic Agonists
Hemostatics
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Natriuretic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Antidiuretic Agents

ClinicalTrials.gov processed this record on January 13, 2009