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A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure

NCT01654835 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-01-25

No results posted yet for this study

Summary

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.

Conditions

  • Intraoperative Low Blood Pressure

Interventions

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."

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01654835 on ClinicalTrials.gov