Continuous Infusion of Terlipressin in Septic Shock

Septic Shock Clinical Trial

Official title:

Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. "THE TERLIVAP STUDY"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481572
• Other study ID #: 1124
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2007
• Last updated: February 26, 2008
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2008
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Terlipressin
continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs
• Vasopressin
continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs
• Norepinephrine
titrated norepinephrine over a period of 48 hrs

Locations

Country	Name	City	State
Italy	Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"	Rome, Viale del Policlinico 155

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic and regional hemodynamics		during the first 48 hours from the onset of septic shock	Yes
Secondary	Markers of inflammation,organ functions,adverse effects.		during the first 48 hours from the onset of septic shock	Yes