Hemodynamic Effects of Vasopressin in Early Septic Shock Stage

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Flavia Ribeiro Machado, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT02053675
First received: May 28, 2013
Last updated: January 31, 2014
Last verified: May 2010
  Purpose

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.


Condition Intervention
Septic Shock
Drug: Vasopressin infusion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Hemodynamic Effects of Low Doses of Arginine Vasopressin in Early Septic Shock Stage

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 18
Study Start Date: May 2008
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vasopressin Drug: Vasopressin infusion

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Acute coronary disease
  • Suspected or confirmed acute mesenteric ischemia
  • Severe hyponatremia (Na + <130 mmol / L)
  • Raynaud's phenomenon
  • Sclerodermia
  • Pregnancy
  • Technical difficulties to capture videomicroscopy with sublingual SDF
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02053675

Locations
Brazil
Hospital São Paulo
São Paulo, São Paulo/SP, Brazil, 04024900
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
  More Information

No publications provided

Responsible Party: Flavia Ribeiro Machado, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02053675     History of Changes
Other Study ID Numbers: Vasopress FAPESP 2010/50096-6
Study First Received: May 28, 2013
Last Updated: January 31, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
septic shock
vasopressin
microcirculation
tissue oxygenation
vasopressors
hemodynamics

Additional relevant MeSH terms:
Shock
Shock, Septic
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Arginine Vasopressin
Vasopressins
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on May 21, 2015