Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

NCT01618396 | Completed

• 1 other identifier: CSSJ001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock,; Sepsis

Keywords

Microcirculation; Hypnotics and Sedatives,; Propofol,; Midazolam

Outcome Measures

Primary Outcomes (1)

• 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

  Just before stopping propofol and thirty minutes after the start of midazolam infusion

Interventions

Sedation drug (Propofol and Midazolam) DRUG

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Septic shock patients needing mechanical ventilation in pressure or volume-controlled mode.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Casa de Saúde São José: lead

Study Sites (1)

Casa de Saude Sao Jose

Rio de Janeiro, Rio de Janeiro, 22271-080, Brazil

Location

Related Publications (6)

• 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.

  PMID: 10816184 BACKGROUND

• 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.

  PMID: 18191684 BACKGROUND

• 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.

  PMID: 12091178 BACKGROUND

• 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.

  PMID: 15343008 BACKGROUND

• 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.

  PMID: 17845716 BACKGROUND

• 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.

  PMID: 18653494 BACKGROUND

MeSH Terms

Conditions

Shock; Sepsis

Interventions

Propofol; Midazolam

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Guilherme Penna, MD, MsC

  State University of Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

BR (1)