ShockHIINCT02185521

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

A study testing patient assessment in people with Shock and Hemodynamic Instability, run by Philips Healthcare at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Shock, Hemodynamic Instability
What is being tested?: patient assessment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 2 sitesUnited States
Study dates: 1 Mar 2016to 18 Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Alpert Medical School of Brown University, Rhode Island Hospital, Medical Intensive Care Unit
Providence, Rhode Island, 02903
Washington University in St. Louis School of Medicine, Department of Surgery, Section of Acute and Critical Care Surgery
St Louis, Missouri, 63110-1093

Other trials in United States

About this study

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

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.

Conditions: Shock, Hemodynamic Instability
Being tested: patient assessment
Keywords: Hemodynamics, Medical Informatics
Medical subject headings: Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

patient assessmentOther
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.

Study groups in NCT02185521
Study group	Role	What they receive
visible HII - patient assessment	Experimental	Clinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system for individual subjects randomized into HII group arm. If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment. Receives: Other: patient assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Intensive Care Unit (ICU) Length of Stay
Measured: 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 (1)

Intensive Care Unit (ICU) Mortality
Measured: From date of randomization of the study subject until the date of ICU discharge, an average of 6.7 days..

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201618 Nov 2016

First posted9 Jul 2014 (estimated)
Study start1 Mar 2016
Primary completion18 Nov 2016
Study completion18 Nov 2016

Why it stopped: Initial main phase completed but recruitment rate was too slow to continue.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ShockStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02185521
Sponsor's protocol ID: 2917-05-12-433
Acronym: HII
Status last verified: May 2019
First submitted: 24 Jun 2014
Last updated: 11 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome

All Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hemodynamic Instability Rules Based Advisor: The Impact to Care With a New Predictive Indicator (HIRBA 2.0)
ClinicalTrials.gov ID: NCT02185521
Acronym / sponsor ID: HII / 2917-05-12-433
Conditions: Shock, Hemodynamic Instability
Keywords: Hemodynamics, Medical Informatics
Study type: Interventional
Recruitment status: TerminatedReason stopped: Initial main phase completed but recruitment rate was too slow to continue.
Enrolment: 127 participants (actual)
Lead sponsor: Philips HealthcareIndustry (pharma, biotech, devices)
Collaborators: Philips Clinical & Medical Affairs Global
Study start: 1 Mar 2016 (actual)
Primary completion: 18 Nov 2016 (actual)
Study completion: 18 Nov 2016 (actual)
First posted: 9 Jul 2014 (estimated)
Results: Posted 7 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
visible HII - patient assessment	Experimental	Other: patient assessmentClinical team from study unit will observe the Hemodynamic Instability Index created by the HIRBA 2.0 system for individual subjects randomized into HII group arm. If the HII value will cross the threshold, indicative of hemodynamic deterioration, subject from the study arm will receive intervention: clinical assessment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
patient assessmentPatient 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.	Other	visible HII - patient assessment

Primary outcome

Intensive Care Unit (ICU) Length of Stay
Time frame: 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.

1 secondary outcome

Intensive Care Unit (ICU) Mortality
Time frame: From date of randomization of the study subject until the date of ICU discharge, an average of 6.7 days..

Results and safety

Results posted to the registry on 7 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Visible HII - Patient Assessment	127	125

Primary outcome: Intensive Care Unit (ICU) Length of Stay

Time frame: 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.. Mean (Standard Deviation). Unit: days

Measure	Visible HII - Patient Assessment n = 125
Value	6.68 (9.57)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Visible HII - Patient Assessment	0 of 127 (0%)	0 of 127 (0%)	12 of 127

Limitations and caveats (from the sponsor): Slow recruitment led to early termination of the study; generalizability to other ICU settings; lack of further analyses due to small sample size and data collected (timing of intervention, morbidity, cost reduction).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Shock

Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Grant V Bochicchio, MD principal investigator

Washington University School of Medicine

Mitchell M Levy, MD principal investigator

Alpert Medical School of Brown University, Rhode Island Hospital, Providence RI

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing patient assessment in people with Shock and Hemodynamic Instability, run by Philips Healthcare at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensive Care Unit (ICU) Length of Stay (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02185521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.