Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guilherme Loures Penna, Casa de Saúde São José
ClinicalTrials.gov Identifier:
NCT01618396
First received: June 11, 2012
Last updated: June 12, 2012
Last verified: June 2012

June 11, 2012
June 12, 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 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01618396 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01618396
CSSJ001
No
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