A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure
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Purpose
The investigators thus propose to use an innovative randomized effectiveness trial design to test the theory that early automatic identification of a ¡ Low Systolic Blood Pressure¡± clinical condition and decision-support alerts will prompt earlier hemodynamic support and a consequently reduce the duration of such conditions. Specifically, the investigators will test the hypothesis that providing DSS alerts in regards to hypotension reduces the duration of hypotensive episodes. The core of the investigators study will be an existing electronic anesthesia record and smart-alarm decision-support system. All patients undergoing surgery at Hillcrest will be randomly assigned to routine care or to DSS support. In patients assigned to DSS support, a systolic blood pressure less than 80 mmHg will generate a warning within three minutes after detection. Clinicians will be free to act on the alert, ignore the alert, or to consider the provided information without acting on it. The randomization, complete anesthesia record, detailed record of hypotensive events, alerts provided, clinician responses, and SAP response, will be captured by the investigators electronic record-keeping system. The investigators primary outcome will be the duration of time the patient has a systolic blood pressure less than 80 mmHg. Secondary outcome will be duration of hospitalization. The investigators will assess the effect of the alert on the primary outcome of time to SBP returning to above 80 mmHg using survival analysis, with time to event censored (and considered a non-event) at either the end of surgery or end of monitoring if patient did not return to above 80 mmHg.
| Condition | Intervention |
|---|---|
|
Intraoperative Low Blood Pressure |
Other: low blood pressure alert Other: standard of care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
- duration of time having low blood pressure [ Time Frame: day 1 ] [ Designated as safety issue: No ]We plan to test the hypothesis that providing hypotension alerts reduces the duration of time patients spend in a low blood pressure condition.
- hypotension [ Time Frame: day 1 ] [ Designated as safety issue: No ]Secondary outcome will be the incidence of hypotension as well as duration of hospitalization
- duration of hospitalization [ Time Frame: up to day 3 ] [ Designated as safety issue: No ]Secondary outcome will be the incidence of hypotension as well as duration of hospitalization
| Estimated Enrollment: | 711 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: low blood pressure alert
A Low Blood Pressure condition as specified (SAP <80 mmHg)will trigger an page to be sent to all anesthesia providers in <1 min that will read: "A Low Blood Pressure condition has been detected. Consider hemodynamic support."
|
Other: low blood pressure alert
A Low Blood Pressure condition as specified (SAP <80 mmHg)will trigger an page to be sent to all anesthesia providers in <1 min that will read: "A Low Blood Pressure condition has been detected. Consider hemodynamic support."
|
|
Placebo Comparator: no low blood pressure alert
The Low Blood Pressure condition will be monitored by treatment team, but additional alert will not be sent to treatment team.
|
Other: standard of care
A Low Blood Pressure condition as specified (SAP <80 mmHg)will be monitored by treatment team upon detection, but additional paged alert will not be generated.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients will be enrolled in the study if systolic blood pressure (SBP) is measured to be below 80 mmHg for at least 3 minutes, either with the arterial line or cuff (non-invasive blood pressure, NIBP).
Contacts and Locations| United States, Ohio | |
| Hillcrest Hospital Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Andrea Kurz, M.D. 216-445-9924 ak@or.org | |
| Contact: Gretchen Upton 216-445-6500 uptong@ccf.org | |
| Principal Investigator: Andrea Kurz, M.d. | |
More Information
No publications provided
| Responsible Party: | The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT01654835 History of Changes |
| Other Study ID Numbers: | 12-587 |
| Study First Received: | July 17, 2012 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hypotension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013