Prospective Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome After Surgery

NCT ID: NCT02217969

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2023-09-30

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Electronic alert to SLUScore increase

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

Group Type: EXPERIMENTAL

Electronic alert to SLUScore increase

Intervention Type: BEHAVIORAL

Treat hypotension to minimize further progression of the SLUScore

Control (no alert)

Routine anesthesia care at the discretion of the anesthesia care team

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Electronic alert to SLUScore increase

Treat hypotension to minimize further progression of the SLUScore

Intervention Type: BEHAVIORAL

Other Intervention Names

Treat hypotension

Eligibility Criteria

Inclusion Criteria

• Any adult patient presenting for any type of non-cardiac procedure performed under any type of anesthesia

Exclusion Criteria

• Pediatric patients (< 18 yrs of age)
• Obstetric patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Wolf H. Stapelfeldt, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolf H. Stapelfeldt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Saint Louis University School of Medicine

Locations

Saint Louis University Hospital

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.thelancet.com/protocol-reviews-list

Link to the full protocol on The Lancet's web site

Other Identifiers

IRB # 24886

Identifier Type: -

Identifier Source: org_study_id