Study Stopped
IRB application withdrawn
Prospective Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome After Surgery
SLUScore™
Prospective, Randomized Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome Following Adult Non-Cardiac Surgical Procedures: The SLUScore™ Trial
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Patients undergoing anesthesia for non-cardiac surgery will be randomized to either having their anesthesia team alerted or kept blinded to extended periods of less than normal blood pressure with the goal of studying if providing these alerts leads to improved outcome after surgery (lower risk of death or complication in the days and weeks following surgery).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedMarch 14, 2018
March 1, 2018
4 years
August 13, 2014
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
30-day all-cause postoperative mortality
This addresses the known rather high rate of death within 30 days following non-cardiac surgical or interventional procedures
30-days
Secondary Outcomes (1)
Composite outcomes
one week
Other Outcomes (1)
Length of Hospital Stay
30 days
Study Arms (2)
Electronic alert to SLUScore increase
EXPERIMENTALPatients whose anesthesia care team members are receiving alerts to increments in their SLUScore (progressive hypotensive exposures) are anticipated to be given interventions aimed at minimizing further hypotensive exposures. The decision of whether or not to intervene as well as the type(s) of interventions will be at the sole discretion of the patient's anesthesia care team
Control (no alert)
NO INTERVENTIONRoutine anesthesia care at the discretion of the anesthesia care team
Interventions
Treat hypotension to minimize further progression of the SLUScore
Eligibility Criteria
You may qualify if:
- Any adult patient presenting for any type of non-cardiac procedure performed under any type of anesthesia
You may not qualify if:
- Pediatric patients (\< 18 yrs of age)
- Obstetric patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolf H. Stapelfeldt, M.D.
Saint Louis University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 13, 2014
First Posted
August 15, 2014
Study Start
July 1, 2018
Primary Completion
July 1, 2022
Study Completion
September 1, 2023
Last Updated
March 14, 2018
Record last verified: 2018-03