Sedation Awakening for Critical Illness

AP
John P Kress, MD profile photo
Overseen ByJohn P Kress, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
Must be taking: Vasoactive drugs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of daily awakening of sedated patients on the medication required to maintain stable blood pressure in the ICU. It focuses on patients who need mechanical ventilation and medication for shock. Participants must be on a ventilator with sedation and require medication through a central line for shock, but they must not be using the sedative dexmedetomidine. As an unphased trial, this study provides patients the opportunity to contribute to important research that could enhance ICU care practices.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking Dexmedetomidine as a sedative.

What prior data suggests that this protocol is safe for ICU patients?

Research has shown that the level of sedation in very sick adults does not increase the risk of death, confusion, or other serious side effects. Studies have also found that taking breaks from sedation can help patients spend less time on breathing machines and leave the ICU sooner. Specifically, one study found that combining sedation breaks with breathing exercises reduced the number of days patients needed help to breathe.

Overall, sedation breaks are generally well-tolerated, meaning patients usually handle them without serious problems. It is important to know that prolonged sedation can lead to more time on breathing machines and increase the risk of lung infections and confusion. Therefore, careful management of sedation is crucial for safety and recovery.12345

Why are researchers excited about this trial?

Researchers are excited about the Sedation Awakening Trial (SAT) because it aims to improve outcomes for ICU patients undergoing mechanical ventilation while requiring vasoactive drug infusions for shock. Unlike the traditional continuous sedation methods, SAT involves periodically stopping sedation to assess a patient's neurological status, potentially reducing ventilation duration and improving recovery times. This approach is different because it balances the need for sedation with the benefits of reducing sedative exposure, which could enhance patient outcomes and reduce ICU stays.

What evidence suggests that daily awakening from sedation is effective in reducing vasoactive medication in ICU patients?

Research shows that waking ICU patients on ventilators daily, a process called Sedation Awakening Trials, can lead to better outcomes. In this trial, participants will undergo Sedation Awakening Trials as part of their treatment. Studies have found that these trials can shorten the time patients need mechanical ventilation and reduce their stay in the ICU. Additionally, maintaining lighter sedation levels might decrease the risk of death in critically ill patients by 25%. Evidence also indicates that these trials can result in fewer complications and less mental impairment. Overall, these trials have been linked to better recovery and fewer problems related to sedation.26789

Who Is on the Research Team?

JK

John Kress, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

Inclusion Criteria

requiring Mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic agent for comfort
requiring vasoactive drug via central venous catheter for the treatment of shock

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

Observation

Observation of mean arterial pressure and vasoactive drug dose before and during the awakening from sedation trial

<1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the observation period

1 day

What Are the Treatments Tested in This Trial?

Interventions

  • Sedation Awakening Trial
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Mechanical Ventilation (MV) with vasoactive infusionsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Citations

Implementation of coordinated spontaneous awakening and ...Spontaneous awakening and breathing trials during mechanical ventilation improve patient outcomes. Daily interruptions in sedation [spontaneous ...
Effect of level of sedation on outcomes in critically ill adult ...Our hypothesis was that lighter sedation compared with deeper sedation reduces the risk of death by 25% in critically ill adult patients admitted to the ICU.
a comprehensive evaluation of protocolized sedation in ...This study endeavors to comprehensively assess the effectiveness and safety of protocolized sedation in critically ill ventilated patients.
Spontaneous Awakening Trials and ...Study findings showed that weaning protocol was associated with significant reduction for duration of mechanical ventilation, length of weaning, and length of ...
Pairing Spontaneous Awakening and Breathing Trials to ...Outcomes included weaning success, mechanical ventilation (MV) duration, sedation time, complications, cognitive impairment, ICU stay length, and mortality.
Factors Associated With Spontaneous Awakening Trial and ...Compared with those with a higher level of arousal, patients who were deeply sedated or in coma had significantly lower odds of having a next-day SAT (AOR, 0.69 ...
Nonsedation or Light Sedation in Critically Ill, Mechanically ...A trial comparing daily interruption of sedation with no interruption showed that patients had shorter durations of mechanical ventilation and shorter stays in ...
Coordinated Spontaneous Awakening and Breathing Trials ...Girard et al. showed that when paired, the SAT and SBT reduced the number of days patients were on mechanical ventilation (3.1-day reduction, 95% confidence ...
Implementation of coordinated spontaneous awakening and ...Prolonged sedation and analgesia, however, may increase time on mechanical ventilation, risk for ventilator associated pneumonia, and delirium.
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