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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00481572

Enrollment

Registered

2007-06-01

Start date

2007-01-31

Completion date

2007-12-31

Last updated

2008-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

Sepsis, Septic Shock, vasopressin, terlipressin

Brief 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.

Interventions

DRUGTerlipressin

continuous terlipressin infusion 1.3 µg•kg-1 over a period of 48 hrs

DRUGVasopressin

continuous intravenous infusion of vasopressin 0.03 U•min-1 over a period of 48 hrs

DRUGNorepinephrine

titrated norepinephrine over a period of 48 hrs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Systemic and regional hemodynamics	during the first 48 hours from the onset of septic shock

Secondary

Measure	Time frame
Markers of inflammation,organ functions,adverse effects.	during the first 48 hours from the onset of septic shock

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026