Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

Sepsis Clinical Trial

Official title:

Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618396
• Other study ID #: CSSJ001
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: June 12, 2012
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: Casa de Saúde São José
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Shock
• Shock,

Intervention

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.

Locations

Country	Name	City	State
Brazil	Casa de Saude Sao Jose	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Casa de Saúde São José

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No