Critical IllnessNCT02892669
Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department
An observational study of Critical Illness, run by Rambam Health Care Campus.
Trial summary
This study is designed to evaluate the predictive value of heart rate variability on medial outcome in patients admitted to the intensive care department Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- non interventional study
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients admitted to the intensive care department
Who may be able to join
- adults admitted to ICU
Who cannot join
- rhythm other then sinus
- presence of cardiac pacemaker
Trial locations and contacts
No sites are listed yet.
About this study
This study is designed to evaluate the predictive value of heart rate variability on medial outcome in patients admitted to the intensive care department
- Conditions
- Critical Illness
- Being tested
- non interventional study
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventional studyOther
non interventional study
| Study group | Role | What they receive |
|---|---|---|
| patients admitted to the intensive care department | Not described Receives: Other: non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 6 months
Secondary outcomes (2)
ICU stay
Measured: 6 months
Hospital stay
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amit Lehavi MD FANZCA, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892669
- Sponsor's protocol ID
- RRV ICU ADMISSION
- Status last verified
- Sep 2016
- First submitted
- 2 Sep 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department
- ClinicalTrials.gov ID
- NCT02892669
- Acronym / sponsor ID
- RRV ICU ADMISSION
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the predictive value of heart rate variability on medial outcome in patients admitted to the intensive care department
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients admitted to the intensive care department | – | Other: non interventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care department
Key inclusion criteria (1 listed)
- adults admitted to ICU
Key exclusion criteria (2 listed)
- rhythm other then sinus
- presence of cardiac pacemaker
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 |
|---|---|---|
| non interventional studynon interventional study | Other | patients admitted to the intensive care department |
Primary outcome
Mortality
Time frame: 6 months
2 secondary outcomes
ICU stay
Time frame: 6 months
Hospital stay
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Rambam Health Care Campus.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit Lehavi, MD (972-50-20161419, amit.lehavi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2016.