Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock - Full Text View

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:

MedlinePlus related topics: Sepsis Shock

Drug Information available for: Propofol Midazolam hydrochloride

U.S. FDA Resources

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:

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

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:

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.

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.

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.

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.

De Backer D, Hollenberg S, Boerma C, Goedhart P, Büchele 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.

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. Epub 2008 Jul 23.

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:

Sepsis
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Midazolam
Hypnotics and Sedatives
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013