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Completed

NCT Number: NCT01618396

Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Casa de Saude Sao Jose

Rio de Janeiro, 22271-080, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Sublingual Microcirculatory Variables

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

    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

Sponsors and collaborators

Lead sponsor

Casa de Saúde São José

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 13, 2012
Registry last updated
Jun 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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