Hemodynamic Instability Index: The Impact to Care With a New Predictive Indicator

Shock Clinical Trial

— HII  

Official title:

Hemodynamic Instability Rules Based Advisor: The Impact to Care With a New Predictive Indicator (HIRBA 2.0)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02185521
• Other study ID #: 2917-05-12-433
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: November 18, 2016

Study information

• Verified date: May 2019
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 127
• Est. completion date: November 18, 2016
• Est. primary completion date: November 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamic Instability
• Shock

Intervention

Other:
• patient assessment
Patient clinician status assessment based on Hemodynamic Instability Indicator (HII) trend. The HII indicator combines existing data such as physiologic parameters (Heart Rate, HR; Blood Pressure, BP), laboratory measurements (Albumin; Hematocrit, HCT; Bicarbonate; White Blood Cell, WBC; Blood Urea Nitrogen, BUN), and ADT information (age). HII will be displayed on charting workstation (Workstation on Wheels, WOW). Nurse's role will be to observe the value of HII while accessing WOW desktop (during regular charting), interpret HII value, and share this information to the physician when indicative of potential patient hemodynamic instability to trigger patient clinical status assessment. This intervention is associated with Experimental Study Arm: visible HII.

Locations

Country	Name	City	State
United States	Alpert Medical School of Brown University, Rhode Island Hospital, Medical Intensive Care Unit	Providence	Rhode Island
United States	Washington University in St. Louis School of Medicine, Department of Surgery, Section of Acute and Critical Care Surgery	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Philips Healthcare	Philips Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive Care Unit (ICU) Length of Stay		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	Intensive Care Unit (ICU) Mortality		From date of randomization of the study subject until the date of ICU discharge, an average of 6.7 days..