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
  Purpose

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.


Condition Intervention
Shock,
Sepsis
Drug: Sedation drug (Propofol and Midazolam)

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

Resource links provided by NLM:


Further study details as provided by Casa de Saúde São José:

Primary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01618396

Locations
Brazil
Casa de Saude Sao Jose
Rio de Janeiro, Brazil, 22271-080
Sponsors and Collaborators
Casa de Saúde São José
Investigators
Principal Investigator: Guilherme Penna, MD, MsC State University of Rio de Janeiro
  More Information

Publications:
Responsible Party: Guilherme Loures Penna, Principal Investigator, Casa de Saúde São José
ClinicalTrials.gov Identifier: NCT01618396     History of Changes
Other Study ID Numbers: CSSJ001
Study First Received: June 11, 2012
Last Updated: June 12, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Casa de Saúde São José:
Microcirculation
Hypnotics and Sedatives,
Propofol,
Midazolam

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Hypnotics and Sedatives
Midazolam
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014