Hemodynamic InstabilityNCT02945748
Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability
An observational study of Hemodynamic Instability, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Hemodynamically unstable ventilated PICU \& PCICU patients, which a decision for commencement in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic measurements will be carried out before and after therapy have been made, including customary hemodynamic parameters, echocardiography and… Read more about this study
- Who is it for?
- Ages 2 days to 18 years
- Conditions the study is for
- Hemodynamic Instability
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to Aug 2020
- 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 2 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric critically ill ventilated patients addmited to PICU \& PCICU
Who may be able to join
- Pediatric critically ill ventilated patients admitted to PICU \& PCICU
- Hemodynamically unstable which a decision for commencement in inotropic therapy or fluid bolus has been made
- parental concent
Who cannot join
- Cardiac shunt
- Aortal anomaly \ Repair
- Tracheostomy
- Parental refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Hemodynamically unstable ventilated PICU \& PCICU patients, which a decision for commencement in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic measurements will be carried out before and after therapy have been made, including customary hemodynamic parameters, echocardiography and USCOM studies.
All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction. Trend in USCOM parameters will be compared to echocardiography CO parameters.
- Conditions
- Hemodynamic Instability
- Keywords
- pediatric, cardiac output, fluid responsiveness, critically ill, hemodynamic monitoring
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Raise>10% in cardiac index following therapy
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945748
- Sponsor's protocol ID
- 0693-14-RMC
- Status last verified
- Aug 2020
- First submitted
- 25 Oct 2016
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability
- ClinicalTrials.gov ID
- NCT02945748
- Acronym / sponsor ID
- 0693-14-RMC
- Conditions
- Hemodynamic Instability
- Keywords
- pediatric, cardiac output, fluid responsiveness, critically ill, hemodynamic monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 26 Oct 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.
Hemodynamically unstable ventilated PICU \& PCICU patients, which a decision for commencement in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic measurements will be carried out before and after therapy have been made, including customary hemodynamic parameters, echocardiography and USCOM studies.
All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction. Trend in USCOM parameters will be compared to echocardiography CO parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric critically ill ventilated patients addmited to PICU \& PCICU
Key inclusion criteria (3 listed)
- Pediatric critically ill ventilated patients admitted to PICU \& PCICU
- Hemodynamically unstable which a decision for commencement in inotropic therapy or fluid bolus has been made
- parental concent
Key exclusion criteria (4 listed)
- Cardiac shunt
- Aortal anomaly \ Repair
- Tracheostomy
- Parental refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Raise>10% in cardiac index following therapy
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability, run by Rabin Medical Center at 1 site in Israel.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Raise>10% in cardiac index following therapy (time frame: 20 minutes). 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 16 Mar 2021.