Vasopressor SAT Study

NCT03182335 | Active Not Recruiting FDA Drug

• 1 other identifier: 15-1532
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Blood Pressure; Delirium; Critical Illness

Outcome Measures

Primary Outcomes (1)

• change in vasoactive drug dose

  mcg/kg/min baseline dose and nadir dose

  baseline thru study completion on average < 4 hrs

Secondary Outcomes (2)

• change in mean arterial blood pressure

  baseline thru study completion on average <4 hrs

• change in prevalence of ICU delirium

  baseline thru study completion on average <4hrs

Study Arms (1)

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

Interventions

sedation awakening trial OTHER

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

Also known as: SAT

Mechanical Ventilation (MV) with vasoactive infusions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patients admitted to the intensive care unit

You may qualify if:

• 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

You may not qualify if:

• patients receiving Dexmedetomidine as sedative

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Hypotension; Delirium; Critical Illness

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• John Kress, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 9, 2017
• Study Start: April 28, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (1)