A Phase 2 interventional study of Terlipressin and Vasopressin in Septic Shock, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-02-29.
Sponsored by University of Roma La Sapienza · Phase 2, Interventional, and Treatment
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.
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 45 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Terlipressin
Drug: Terlipressin
Vasopressin
Drug: Vasopressin
titrated norepinephrine
Drug: Norepinephrine
continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs
continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs
titrated norepinephrine over a period of 48 hrs
Systemic and regional hemodynamics
Time frame: during the first 48 hours from the onset of septic shock
Markers of inflammation,organ functions,adverse effects.
Time frame: during the first 48 hours from the onset of septic shock
This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza