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Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

Primary Purpose

Shock,, Sepsis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sedation drug (Propofol and Midazolam)
Sponsored by
Casa de Saúde São José
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock, focused on measuring Microcirculation, Hypnotics and Sedatives,, Propofol,, Midazolam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Casa de Saude Sao Jose

Outcomes

Primary Outcome Measures

Sublingual Microcirculatory Variables
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

Secondary Outcome Measures

Full Information

First Posted
June 11, 2012
Last Updated
June 12, 2012
Sponsor
Casa de Saúde São José
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1. Study Identification

Unique Protocol Identification Number
NCT01618396
Brief Title
Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock
Official Title
Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Casa de Saúde São José

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock,, Sepsis
Keywords
Microcirculation, Hypnotics and Sedatives,, Propofol,, Midazolam

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sedation drug (Propofol and Midazolam)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sublingual Microcirculatory Variables
Description
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
Time Frame
Just before stopping propofol and thirty minutes after the start of midazolam infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilherme Penna, MD, MsC
Organizational Affiliation
State University of Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casa de Saude Sao Jose
City
Rio de Janeiro
ZIP/Postal Code
22271-080
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
10816184
Citation
Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
Results Reference
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PubMed Identifier
18191684
Citation
Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
Results Reference
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PubMed Identifier
12091178
Citation
De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul 1;166(1):98-104. doi: 10.1164/rccm.200109-016oc.
Results Reference
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PubMed Identifier
15343008
Citation
Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. doi: 10.1097/01.ccm.0000138558.16257.3f.
Results Reference
background
PubMed Identifier
17845716
Citation
De Backer D, Hollenberg S, Boerma C, Goedhart P, Buchele G, Ospina-Tascon G, Dobbe I, Ince C. How to evaluate the microcirculation: report of a round table conference. Crit Care. 2007;11(5):R101. doi: 10.1186/cc6118.
Results Reference
background
PubMed Identifier
18653494
Citation
Koch M, De Backer D, Vincent JL, Barvais L, Hennart D, Schmartz D. Effects of propofol on human microcirculation. Br J Anaesth. 2008 Oct;101(4):473-8. doi: 10.1093/bja/aen210. Epub 2008 Jul 23.
Results Reference
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Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

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