Vasopressor SAT Study

Active, not recruiting

• Conditions: Delirium; Critical Illness; Low Blood Pressure
• Interventions: Other: sedation awakening trial

• Registration Number: NCT03182335
• Lead Sponsor: University of Chicago

Brief Summary

To assess the impact of daily awakening from sedation on the amount of vasoactive medication required in the ICU. The hypothesis of this proposal is that the amount of vasoactive drug required to maintain an adequate mean arterial blood pressure will be reduced during a daily awakening from sedation.

Detailed Description

This observational study will compare mean arterial pressure and vasoactive drug dose recorded at two time points:

1. prior to awakening from sedation

2. during the awakening from sedation trial The vasoactive infusion will be titrated to a mean arterial pressure as determined by the medical team prior to study enrollment. Each enrolled patient will have measurements taken only on the first day of enrollment. Enrolled subjects will also have a delirium assessment using the CAM-ICU tool before the awakening from sedation trial and during the awakening from sedation trial.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04-28
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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

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Exclusion Criteria

• patients receiving Dexmedetomidine as sedative

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanical Ventilation (MV) with vasoactive infusions	sedation awakening trial	adult ICU patients who are mechanically ventilated with sedative infusion and/or analgesic infusion and also requiring vasoactive drug infusions for the treatment of shock. Patients will be excluded if receiving dexmedetomidine as sedative.

Primary Outcome Measures

Name	Time	Method
change in vasoactive drug dose	baseline thru study completion on average < 4 hrs	mcg/kg/min baseline dose and nadir dose

Secondary Outcome Measures

Name	Time	Method
change in mean arterial blood pressure	baseline thru study completion on average <4 hrs	mm Hg
change in prevalence of ICU delirium	baseline thru study completion on average <4hrs	CAM ICU score

Trial Locations

Locations (1)

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States