Sepsis Clinical Trial
Official title:
Vasopressin Receptor Agonists in Septic Shock: Effects on Microcirculation
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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