Hemodynamic Effects of Vasopressin in Early Septic Shock Stage
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ClinicalTrials.gov Identifier: NCT02053675
Recruitment Status :
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Flavia Ribeiro Machado, Federal University of São Paulo
Vasopressin is a vasopressor used in patients with septic shock. However, its systemic hemodynamic effects and its microcirculation effects are not completely known and understood. This study aimed to evaluate the effect of exogenous vasopressin on sublingual microcirculation using the sidestream dark field technique and to correlate it with its systemic effects. To this prospective interventional study, patients with septic shock were included during the first 48 hours of use of catecholamine vasopressors, admitted to the intensive care unit of a university hospital. Vasopressin was administered at 0.04 U / min for one hour. Systemic hemodynamic measurements were obtained immediately before and 1 hour after vasopressin. In addition, images of sublingual microcirculation were collected through sidestream dark field technology. Further analysis with specific software was done after.
The primary objective of this study was to evaluate the effect of vasopressin infusion in microcirculation of septic shock patients [ Time Frame: one hour after vasopressin initiation ]
Significant changes in microcirculatory parameters - MFI (absolute number), TVD (mm/mm2), PVD (mm/mm2), PPV (%), HI (%)
Secondary Outcome Measures :
The secondary objectives were to evaluate the effects of vasopressin on macrocirculation, and correlate potential microcirculatory effects related to its use, with baseline systemic circulation and microcirculation. [ Time Frame: one hour after vasopressin initiation ]
Significant changes in HR (bpm), CI (L/min.m2), SI (ml/beat/m2), oxigen delivery (ml/min), lactate (mg/dL), CO2 gradient (mmHg), and correlation between these changes and potential microcirculatory parameters alteration (MFI, TVD, PVD, PPV, HI)
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients over 18 years
Septic shock using adrenergic vasopressors for less than 48 hours
Arterial catheter and pulmonary artery catheter with semi measurement of cardiac output by thermodilution (Vigilance, Edwards Lifesciences, Irvine, CA, USA) inserted
Signed consent declaration
Acute coronary disease
Suspected or confirmed acute mesenteric ischemia
Severe hyponatremia (Na + <130 mmol / L)
Technical difficulties to capture videomicroscopy with sublingual SDF