Vasopressor SAT Study

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03182335
• Other study ID #: 15-1532
• Status: Active, not recruiting
• Start date: April 28, 2014
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Hypotension
• Low Blood Pressure

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in vasoactive drug dose	mcg/kg/min baseline dose and nadir dose	baseline thru study completion on average < 4 hrs
Secondary	change in mean arterial blood pressure	mm Hg	baseline thru study completion on average <4 hrs
Secondary	change in prevalence of ICU delirium	CAM ICU score	baseline thru study completion on average <4hrs