AnesthesiaSLUScore™NCT02217969
Prospective Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome After Surgery
A study testing Electronic alert to SLUScore increase in people with Anesthesia and Hypotension, run by St. Louis University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Hypotension
- What is being tested?
- Electronic alert to SLUScore increase
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2018to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult patient presenting for any type of non-cardiac procedure performed under any type of anesthesia
Who cannot join
- Pediatric patients (< 18 yrs of age)
- Obstetric patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis University Hospital
St Louis, Missouri, 63110
About this study
Official title: Prospective, Randomized Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome Following Adult Non-Cardiac Surgical Procedures: The SLUScore™ Trial
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).
Read the detailed description
Background:
We recently identified a significant association of postoperative morbidity and 30-day mortality with the concept of "hypotensive exposures" during anaesthesia. Specifically, we found in approximately 160,000 patients from 3 institutions (Cleveland Clinic, Vanderbilt University and Saint Louis University) that roughly every third adult patient undergoing a non-cardiac procedure under anaesthesia experienced twice the 30-day all-cause mortality portended by extended cumulative periods of less than normal intraoperative blood pressure. This association was independent of co-morbidity (Charlson Co-morbidity index), causing the same relative increase in mortality in "healthy" as in "sick" patients. A new method was introduced to quantify hypotensive exposures in form of a novel risk score called the SLUScore™, a score with values from ranging from 0 (no hypotensive exposure) to a maximum of 31 (the maximal number of exposures exceeded of a certain risk-based set of limits for time accumulated at a mean arterial blood pressure below thresholds between 75 and 45 mm Hg), with each increment of the SLUScore™ portending an equivalent 5% increase in 30-day postoperative mortality.
Hypothesis:
We test the hypothesis that alerting the anaesthesia care team to progressive hypotensive exposures (a progressive increase in their SLUScore™) improves 30-day survival. This will be tested in a prospective, randomised trial.
Methods and Design:
A novel Clinical Decision Support System (ACG-Anesthesia by Talis Clinical, LLC) will be used to alert anaesthesia care team members to patients' SLUScores™ in near real time (within 1 minute of documented exposures). At the time of transition from a SLUScore™ of 0 to 1 (occurring in approximately every third anaesthetic), patients will be automatically randomized by the ACG-Anesthesia system to either alert or no alert (blinded) status with the intent of raising awareness on the part of the anaesthesia care team in the alert group of the occurrence of extended hypotensive exposures and their associated risk, allowing the team to render its best clinical judgment to initiate interventions aimed at bringing patients out of progressive hypotensive states. With one interim analysis planned after two years, a total of 56,248 patients are projected to be enrolled over a 4-year period for this trial to be powered to detect a 0.3% absolute reduction in 30-day mortality, by saving at least 50 lives in the alert group after two years (two-sided p<0.016) or at least 70 lives (two-sided p<0.019) at the conclusion of the trial.
- Conditions
- Anesthesia, Hypotension
- Being tested
- Electronic alert to SLUScore increase
- Keywords
- Anesthesia, Hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic alert to SLUScore increaseBehavioural
Also called Treat hypotension
Treat hypotension to minimize further progression of the SLUScore
| Study group | Role | What they receive |
|---|---|---|
| Electronic alert to SLUScore increase | Experimental | Patients 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 Receives: Behavioral: Electronic alert to SLUScore increase |
| Control (no alert) | No intervention | Routine anesthesia care at the discretion of the anesthesia care team |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30-days
Secondary outcomes (1)
Composite outcomes
Myocardial infarction; renal failure; septic shock
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJul 2018 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: IRB application withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolf H. Stapelfeldt, MD, St. Louis University
- Investigators
- Wolf H. Stapelfeldt, M.D., Principal investigator, Saint Louis University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217969
- Sponsor's protocol ID
- IRB # 24886
- Acronym
- SLUScore™
- Status last verified
- Mar 2018
- First submitted
- 13 Aug 2014
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome Following Adult Non-Cardiac Surgical Procedures: The SLUScore™ Trial
- ClinicalTrials.gov ID
- NCT02217969
- Acronym / sponsor ID
- SLUScore™ / IRB # 24886
- Conditions
- Anesthesia, Hypotension
- Keywords
- Anesthesia, Hypotension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB application withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 15 Aug 2014 (estimated)
- 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.
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).
Detailed description
Background:
We recently identified a significant association of postoperative morbidity and 30-day mortality with the concept of "hypotensive exposures" during anaesthesia. Specifically, we found in approximately 160,000 patients from 3 institutions (Cleveland Clinic, Vanderbilt University and Saint Louis University) that roughly every third adult patient undergoing a non-cardiac procedure under anaesthesia experienced twice the 30-day all-cause mortality portended by extended cumulative periods of less than normal intraoperative blood pressure. This association was independent of co-morbidity (Charlson Co-morbidity index), causing the same relative increase in mortality in "healthy" as in "sick" patients. A new method was introduced to quantify hypotensive exposures in form of a novel risk score called the SLUScore™, a score with values from ranging from 0 (no hypotensive exposure) to a maximum of 31 (the maximal number of exposures exceeded of a certain risk-based set of limits for time accumulated at a mean arterial blood pressure below thresholds between 75 and 45 mm Hg), with each increment of the SLUScore™ portending an equivalent 5% increase in 30-day postoperative mortality.
Hypothesis:
We test the hypothesis that alerting the anaesthesia care team to progressive hypotensive exposures (a progressive increase in their SLUScore™) improves 30-day survival. This will be tested in a prospective, randomised trial.
Methods and Design:
A novel Clinical Decision Support System (ACG-Anesthesia by Talis Clinical, LLC) will be used to alert anaesthesia care team members to patients' SLUScores™ in near real time (within 1 minute of documented exposures). At the time of transition from a SLUScore™ of 0 to 1 (occurring in approximately every third anaesthetic), patients will be automatically randomized by the ACG-Anesthesia system to either alert or no alert (blinded) status with the intent of raising awareness on the part of the anaesthesia care team in the alert group of the occurrence of extended hypotensive exposures and their associated risk, allowing the team to render its best clinical judgment to initiate interventions aimed at bringing patients out of progressive hypotensive states. With one interim analysis planned after two years, a total of 56,248 patients are projected to be enrolled over a 4-year period for this trial to be powered to detect a 0.3% absolute reduction in 30-day mortality, by saving at least 50 lives in the alert group after two years (two-sided p<0.016) or at least 70 lives (two-sided p<0.019) at the conclusion of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic alert to SLUScore increase | Experimental | Behavioral: Electronic alert to SLUScore increasePatients 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 intervention | –Routine anesthesia care at the discretion of the anesthesia care team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient presenting for any type of non-cardiac procedure performed under any type of anesthesia
Key exclusion criteria (2 listed)
- Pediatric patients (< 18 yrs of age)
- Obstetric patients
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 |
|---|---|---|
| Electronic alert to SLUScore increaseAlso: Treat hypotensionTreat hypotension to minimize further progression of the SLUScore | Behavioural | Electronic alert to SLUScore increase |
Primary outcome
30-day all-cause postoperative mortality
Time frame: 30-days
This addresses the known rather high rate of death within 30 days following non-cardiac surgical or interventional procedures
1 secondary outcome
Composite outcomes
Time frame: one week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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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.
Wolf H. Stapelfeldt, M.D. principal investigator
Saint Louis University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic alert to SLUScore increase in people with Anesthesia and Hypotension, run by St. Louis University 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 14 Mar 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
30-day all-cause postoperative mortality (time frame: 30-days). 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 14 Mar 2018.