Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

June 12, 2012 updated by: Guilherme Loures Penna, Casa de Saúde São José
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 22271-080
        • Casa de Saude Sao Jose

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Just before stopping propofol and thirty minutes after the start of midazolam infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa de Saúde São José

Investigators

  • Principal Investigator: Guilherme Penna, MD, MsC, State University of Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Estimate)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSSJ001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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