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Terlipressin in Septic Shock: Effects on Microcirculation

Vasopressin Receptor Agonists in Septic Shock: Effects on Microcirculation

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00995839
Enrollment
60
Registered
2009-10-15
Start date
2008-11-30
Completion date
2010-02-28
Last updated
2010-02-04

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

Conditions

Sepsis, Septic Shock

Keywords

terlipressin, vasopressin, sepsis, septic shock, norepinephrine

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.

Interventions

DRUGcontinuous infusion of terlipressin

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

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

DRUGterlipressin bolus administration

intravenous terlipressin bolus administration at the dose of 0.5 mg

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Oxygen transport variablesover a period of 6 from the time of randomization
Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)over a period of 6 hrs from the time of randomization

Secondary

MeasureTime frame
De Backer scoreover a period of 6 hrs from the time of randomization
Acid-base homeostasisover a period of 6 hrs from the time of randomization
Proportion of Perfused vessels (%) (PPV)over a period of 6 hrs from the time of randomization
Perfused Vessel Density (PVD) (mm/mm2)over a period of 6 hrs from the time of randomization
Functional capillary density (mm/mm2) (FCD)over a period of 6 hrs from the time of randomization

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026