Vasopressor SAT Study

August 13, 2025 updated by: University of Chicago

An Assessment of Vasoactive Medication Dose in Mechanically Ventilated Patients Undergoing Daily Sedation Awakening Trial (SAT)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

adult patients admitted to the intensive care unit

Description

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

Exclusion Criteria:

  • patients receiving Dexmedetomidine as sedative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mechanical Ventilation (MV) with vasoactive infusions
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.
Other: sedation awakening trial
vital signs and delirium assessment (CAM-ICU) at baseline then following routine sedation awakening trial. Patient will thus serve as their own control for these interventions
Other Names:
  • SAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in vasoactive drug dose
Time Frame: baseline thru study completion on average < 4 hrs
mcg/kg/min baseline dose and nadir dose
baseline thru study completion on average < 4 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in mean arterial blood pressure
Time Frame: baseline thru study completion on average <4 hrs
mm Hg
baseline thru study completion on average <4 hrs
change in prevalence of ICU delirium
Time Frame: baseline thru study completion on average <4hrs
CAM ICU score
baseline thru study completion on average <4hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: John Kress, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2014

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-1532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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