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Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01618396
First Posted: June 13, 2012
Last Update Posted: June 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Guilherme Loures Penna, Casa de Saúde São José
June 11, 2012
June 13, 2012
June 14, 2012
March 2011
August 2011   (Final data collection date for primary outcome measure)
Sublingual Microcirculatory Variables [ Time Frame: Just before stopping propofol and thirty minutes after the start of midazolam infusion ]
Patients were sedated with propofol during the first 24 hours after intubation and with midazolam afterwards.Systemic hemodynamics and perfusion parameters were assessed at two time points: just before stopping propofol and thirty minutes after the start of midazolam infusion. At both steps, four microcirculatory sequences were acquired using sidestream darkfield imaging to access sublingual microcirculation
Same as current
No Changes Posted
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Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock
Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock
Previous studies have demonstrated that altered microvascular blood flow is an important marker of severe sepsis. Usually, these patients need invasive ventilatory support, frequent use of sedatives and it is unknown if these agents interfere or not on microvascular blood flow. The goal of this study was to compare effects of propofol and midazolam infusions on sublingual microcirculation of septic shock patients.
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Interventional
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Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Shock,
  • Sepsis
Drug: Sedation drug (Propofol and Midazolam)
Septic patients, after intubation, were initially sedated with propofol. During the second day of mechanical ventilation, propofol infusion was interrupted. When the patient awoke, the sedative drug was changed to midazolam. Sedation target was a Ramsay Scale score of 4 to 5.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Septic shock patients needing mechanical ventilation in pressure or volume-controlled mode.

Exclusion Criteria:

  • age less than 18 years,
  • pregnancy,
  • non-sinus rhythm, and
  • contraindication of daily interruption of sedative drug,
  • mainly with the use of neuromuscular blocking drugs, or
  • patients with intracranial hypertension or epileptical status.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01618396
CSSJ001
No
Not Provided
Not Provided
Guilherme Loures Penna, Casa de Saúde São José
Casa de Saúde São José
Not Provided
Principal Investigator: Guilherme Penna, MD, MsC State University of Rio de Janeiro
Casa de Saúde São José
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP