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

This study is currently recruiting participants.

Verified July 2012 by The Cleveland Clinic

Sponsor:

Information provided by (Responsible Party):

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT01654835

First received: July 17, 2012

Last updated: July 31, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 17, 2012
Last Updated Date	July 31, 2012
Start Date ^ICMJE	July 2012
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 31, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01654835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 31, 2012)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure
Official Title ^ICMJE
Brief 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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Condition ^ICMJE	Intraoperative Low Blood Pressure
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	711
Estimated Completion Date	July 2013
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01654835
Other Study ID Numbers ^ICMJE	12-587
Has Data Monitoring Committee	Yes
Responsible Party	The Cleveland Clinic
Study Sponsor ^ICMJE	The Cleveland Clinic
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	The Cleveland Clinic
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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