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

This study is currently recruiting participants.
Verified February 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01654835
First received: July 17, 2012
Last updated: February 1, 2013
Last verified: February 2013

July 17, 2012
February 1, 2013
July 2012
January 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01654835 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure
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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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Intraoperative Low Blood Pressure
  • 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.
  • 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."
    Intervention: Other: low blood pressure alert
  • 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.
    Intervention: Other: standard of care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
711
July 2014
January 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Not Provided
United States
 
NCT01654835
12-587
Yes
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Not Provided
The Cleveland Clinic
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP