Clinical trial NCT02185521: Hemodynamic Instability Index: The Impact to Care With a New Predictive Indicator
Official title: Hemodynamic Instability Rules Based Advisor: The Impact to Care With a New Predictive Indicator (HIRBA 2.0)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shock
Hemodynamic Instability
Keywords: Hemodynamics
Medical Informatics
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Philips Electronics Nederland B.V. acting through Philips CTO organization
First posted: 2014-07-09
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Philips has developed a new algorithm, called Hemodynamic Instability Rules Based Advisor (HIRBA 2.0) system, for the prediction of hemodynamic instability in critically ill patients, who were not previously known to be at risk. This algorithm provides with the numerical index - Hemodynamic Instability Index (HII) and its trend which are calculated from existing real time data derived from patient's current hospital stay such as heart rate and blood pressure, labs, and Admission - Discharge- Transfer (ADT) data to help healthcare providers obtain information about patient's status and make clinical decisions.

The aim of the study is to determine if the patient clinical information, displayed in the form of HII, can prompt possible patient hemodynamic status change and trigger earlier clinical care team response. We hypothesize that this real-time information on hemodynamic instability and earlier clinical decision making will lead to reduced length of stay (LOS) and ICU mortality relative to standard care practice. Study will also identify if the use of the Philips new algorithm called Hemodynamic Instability Rules Based Advisor (HIRBA 2.0) can improve outcomes for patients admitted to the intensive care units (ICUs).

During this study, upon patient admission to the ICU clinical data collection will begin. Data that will be pulled during the study includes: vital signs, medications, reason for admission to the ICU, treatments that patient may receive.

Research subjects will not be asked to do anything as far as specific activities expected to be accomplished during study participation. Subjects will be involved in the study only during their stay in ICU. HII information will be visible to clinicians, taking care of this patient only during his/ her stay in the study unit.

Study team will collect patient information and have the ability to view the HII for subjects.

Once patient leaves the ICU the study team will collect information on the remainder of patient's hospital course including date of hospital discharge. All collected data will be then fully de-identified and released to Philips for analysis.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the study unit will be invited to participate in the study.
* Study subject has to stay in study unit for at least 12 hours.

Exclusion Criteria:

* Patients who were discharged from study unit earlier then 12 hours after admission.
* Patients who are or become dependent on extracorporeal membrane oxygenation (ECMO) support.

Primary outcomes:
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: From time of the study subject admission to the unit until the day of discharge of that same study subject from the unit, assessed up to 12 months.
Secondary outcomes:
measure: Intensive Care Unit (ICU) Mortality
timeFrame: From date of randomization of the study subject until the date of ICU discharge, an average of 6.7 days..
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis School of Medicine, Department of Surgery, Section of Acute and Critical Care Surgery
state: Missouri
city: Providence
country: United States
facility: Alpert Medical School of Brown University, Rhode Island Hospital, Medical Intensive Care Unit
state: Rhode Island
Study officials:
affiliation: Washington University School of Medicine
name: Grant V Bochicchio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alpert Medical School of Brown University, Rhode Island Hospital, Providence RI
name: Mitchell M Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: