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

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.

Study Overview

• Status: Withdrawn
• Conditions: Intraoperative Low Blood Pressure
• Intervention / Treatment: Other: low blood pressure alert; Other: standard of care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Hillcrest Hospital Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of time having low blood pressure	We plan to test the hypothesis that providing hypotension alerts reduces the duration of time patients spend in a low blood pressure condition.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypotension	Secondary outcome will be the incidence of hypotension as well as duration of hospitalization	day 1
duration of hospitalization	Secondary outcome will be the incidence of hypotension as well as duration of hospitalization	up to day 3

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 31, 2012
• First Posted (Estimate): August 1, 2012

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 12-587