Terlipressin in Septic Shock: Effects on Microcirculation

NCT ID: NCT00995839

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-02-28

Brief Summary

The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.

Detailed Description

60 septic shock patients requiring norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. After an initial hemodynamic resuscitation aimed at achieve a mean arterial pressure between 65 and 75 mmHg and normovolemia, patients will be randomly allocated to be treated with either a) intravenous administration of terlipressin 1 µg∙kg-1∙h-1 for 6 hrs, b) intravenous administration of arginine vasopressin 0.04 UI∙min-1 for 6 hrs, c) intravenous administration of terlipressin bolus dose of 0.5 mg (each n = 20). In all groups open label norepinephrine will be additionally administered to maintain a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization and sublingual microvascular network will be obtained just before randomization (baseline) and then after 6 hours in the vasopressin, terlipressin infusion and terlipressin bolus groups.

The sublingual microvascular network will be studied using the sidestream dark field (SDF)imaging. The device will be applied on the lateral side of the tongue, in an area approximately 2-4 cm from the tip of the tongue. Sequences of 10 secs from eight adjacent areas will be recorded on disk using a personal computer. These sequences will be later analyzed by an investigator blinded to the patient's diagnosis and therapy.

Conditions

Septic Shock; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

continuous terlipressin

Group Type: EXPERIMENTAL

continuous infusion of terlipressin

Intervention Type: DRUG

Intravenous continuous infusion of terlipressin 1 µg•kg-1•h-1 for 6 hrs

vasopressin

Group Type: EXPERIMENTAL

Arginine vasopressin

Intervention Type: DRUG

Intravenous continuous infusion of arginine vasopressin 0.04 UI•min-1 for 6 hrs

terlipressin bolus dose

Group Type: EXPERIMENTAL

terlipressin bolus administration

Intervention Type: DRUG

intravenous terlipressin bolus administration at the dose of 0.5 mg

Interventions

continuous infusion of terlipressin

Intravenous continuous infusion of terlipressin 1 µg•kg-1•h-1 for 6 hrs

Intervention Type: DRUG

Arginine vasopressin

Intravenous continuous infusion of arginine vasopressin 0.04 UI•min-1 for 6 hrs

Intervention Type: DRUG

terlipressin bolus administration

intravenous terlipressin bolus administration at the dose of 0.5 mg

Intervention Type: DRUG

Eligibility Criteria

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
• Age < 18 years
• Present or suspected acute mesenteric ischemia
• Vasospastic diathesis (e.g. Raynaud's syndrome or related diseases)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

University of Rome "La Sapienza"

Principal Investigators

Andrea Morelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care

Locations

Departement of Anesthesiology and Intensive Care

Rome, I, Italy

Countries

Italy

References

Morelli A, Donati A, Ertmer C, Rehberg S, Kampmeier T, Orecchioni A, Di Russo A, D'Egidio A, Landoni G, Lombrano MR, Botticelli L, Valentini A, Zangrillo A, Pietropaoli P, Westphal M. Effects of vasopressinergic receptor agonists on sublingual microcirculation in norepinephrine-dependent septic shock. Crit Care. 2011;15(5):R217. doi: 10.1186/cc10453. Epub 2011 Sep 19.

Reference Type: DERIVED

PMID: 21929764 (View on PubMed)

Other Identifiers

1065

Identifier Type: -

Identifier Source: org_study_id