Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481572
Status:
COMPLETED
Last Update Posted:
2008-02-29
First Post:
2007-05-30
Brief Title:
Continuous Infusion of Terlipressin in Septic Shock
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock A Randomized Controlled Pilot Trial THE TERLIVAP STUDY
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether Athe continuous infusion ultra-low dose of terlipressin 13 microgramskgh is able to stabilize hemodynamic in patients with septic shock reducing the risk of adverse effects related to the bolus doseBthe 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 13 µgkg-1 b vasopressin 003 Umin-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None