Continuous Infusion of Terlipressin in Septic Shock

University of Roma La Sapienza

Status and phase: Completed; Phase 2

Conditions: Septic Shock

Treatments: Drug: Norepinephrine; Drug: Terlipressin; Drug: Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT00481572

1124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

1

Experimental group

Description:

Terlipressin

Treatment:

Drug: Terlipressin

2

Experimental group

Description:

Vasopressin

Treatment:

Drug: Vasopressin

3

Active Comparator group

Description:

titrated norepinephrine

Treatment:

Drug: Norepinephrine