NCT00481572

Continuous Infusion of Terlipressin in Septic Shock

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-06-01
• Last updated: 2008-02-29

Locations

1 site across 1 country: Italy