Low Blood PressureNCT03182335
Vasopressor SAT Study
An observational study of Low Blood Pressure and Delirium, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Blood Pressure, Delirium, Critical Illness
- What is being tested?
- sedation awakening trial
- Type of treatment
- Injection or infusion
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2014to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients admitted to the intensive care unit
Who may be able to join
- 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
Who cannot join
- patients receiving Dexmedetomidine as sedative
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: 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.
Read the detailed description
This observational study will compare mean arterial pressure and vasoactive drug dose recorded at two time points:
- prior to awakening from sedation
- 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.
- Conditions
- Low Blood Pressure, Delirium, Critical Illness
- Being tested
- sedation awakening trial
- Medical subject headings
- Hypotension, Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sedation awakening trialOther
Also called SAT
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: sedation awakening trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in vasoactive drug dose
mcg/kg/min baseline dose and nadir dose
Measured: baseline thru study completion on average < 4 hrs
Secondary outcomes (2)
change in mean arterial blood pressure
mm Hg
Measured: baseline thru study completion on average <4 hrs
change in prevalence of ICU delirium
CAM ICU score
Measured: baseline thru study completion on average <4hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start28 Apr 2014
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Blood PressureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Kress, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182335
- Sponsor's protocol ID
- 15-1532
- Status last verified
- Jul 2026
- First submitted
- 6 Jun 2017
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Vasoactive Medication Dose in Mechanically Ventilated Patients Undergoing Daily Sedation Awakening Trial (SAT)
- ClinicalTrials.gov ID
- NCT03182335
- Acronym / sponsor ID
- 15-1532
- Conditions
- Low Blood Pressure, Delirium, Critical Illness
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 28 Apr 2014 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- prior to awakening from sedation
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical Ventilation (MV) with vasoactive infusions | – | Other: sedation awakening trialadult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients admitted to the intensive care unit
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- patients receiving Dexmedetomidine as sedative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sedation awakening trialAlso: SATvital 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 | Mechanical Ventilation (MV) with vasoactive infusions |
Primary outcome
change in vasoactive drug dose
Time frame: baseline thru study completion on average < 4 hrs
mcg/kg/min baseline dose and nadir dose
2 secondary outcomes
change in mean arterial blood pressure
Time frame: baseline thru study completion on average <4 hrs
change in prevalence of ICU delirium
Time frame: baseline thru study completion on average <4hrs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Low Blood Pressure
Not yet recruitingObservational study
Intelligent Classification of Intraoperative Hemodynamic Phenotypes Based on CADFlow Doppler Monitoring
Ultrasound, Machine Learning
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Recruiting
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
Critical Illness, Shock
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kress, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Blood Pressure and Delirium, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in vasoactive drug dose (time frame: baseline thru study completion on average < 4 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.