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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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
intravenous terlipressin bolus administration at the dose of 0.5 mg
Departement of Anesthesiology and Intensive Care
Rome, I, Italy
Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)
Time frame: over a period of 6 hrs from the time of randomization
Oxygen transport variables
Time frame: over a period of 6 from the time of randomization
Acid-base homeostasis
Time frame: over a period of 6 hrs from the time of randomization
Functional capillary density (mm/mm2) (FCD)
Time frame: over a period of 6 hrs from the time of randomization
De Backer score
Time frame: over a period of 6 hrs from the time of randomization
Perfused Vessel Density (PVD) (mm/mm2)
Time frame: over a period of 6 hrs from the time of randomization
Proportion of Perfused vessels (%) (PPV)
Time frame: over a period of 6 hrs from the time of randomization
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