Vasopressin Receptor Agonists in Septic Shock: Effects on Microcirculation
Overview
- Phase
- Phase 2
- Intervention
- continuous infusion of terlipressin
- Conditions
- Septic Shock
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
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)
Arms & Interventions
continuous terlipressin
Intervention: continuous infusion of terlipressin
vasopressin
Intervention: Arginine vasopressin
terlipressin bolus dose
Intervention: terlipressin bolus administration
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Acid-base homeostasis(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)
- De Backer score(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)
- Proportion of Perfused vessels (%) (PPV)(over a period of 6 hrs from the time of randomization)