Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

NCT ID: NCT01618396

Last Updated: 2012-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Shock, Sepsis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Casa de Saúde São José

OTHER

Sponsor Role lead

Responsible Party

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Guilherme Loures Penna

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guilherme Penna, MD, MsC

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Locations

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Casa de Saude Sao Jose

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 10816184 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18191684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12091178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15343008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17845716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18653494 (View on PubMed)

Other Identifiers

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CSSJ001

Identifier Type: -

Identifier Source: org_study_id

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