Fluid ResponsivenessECHOKIDSNCT01821742
Echocardiography in Kids Intensive Care Decision Support
An observational study of Fluid Responsiveness and Cardiac Output, run by Imperial College London at 1 site in United Kingdom.
Trial summary
A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Fluid Responsiveness, Cardiac Output
- What is being tested?
- Ultrasound cardiac output measurement
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Jul 2013
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Shocked children on PICU
Who may be able to join
- Any ventilated child requiring fluid bolus therapy on the PICU for clinical indications
Who cannot join
- Arrythmia
- Intracardiac shunt
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: Echocardiography in Kids Intensive Care Decision Support - is Focused Echocardiography Superior to Pressure Derived Measurements at Predicting Fluid Responsiveness in Critically Ill Children?
A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU.
Read the detailed description
A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU. These parameters will be measured pre and post fluid bolus in children prescribed fluid bolus therapy for clinical indications on the PICU. Children will be classified as responders (>10% increase in cardiac output) and non responders (<10% increase). Appropriate statistical tests will be performed to determine the most useful predictor of an increase in cardiac output following a fluid bolus.
- Conditions
- Fluid Responsiveness, Cardiac Output
- Being tested
- Ultrasound cardiac output measurement
- Keywords
- Shock, Fluid bolus, Cardiac output, Children in intensive care
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound cardiac output measurementOther
| Study group | Role | What they receive |
|---|---|---|
| Children requiring fluid bolus on PICU | Not described Receives: Other: Ultrasound cardiac output measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness
10% increase in cardiac output following fluid bolus
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Inwald, MB BChir, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821742
- Sponsor's protocol ID
- IRAS ID 121440
- Acronym
- ECHOKIDS
- Status last verified
- Jul 2019
- First submitted
- 22 Mar 2013
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McLean JRL, Inwald DP. The utility of stroke volume variability as a predictor of fluid responsiveness in critically ill children: a pilot study. Intensive Care Med. 2014 Feb;40(2):288-289. doi: 10.1007/s00134-013-3171-x. Epub 2013 Dec 5. No abstract available.
PubMed 24306083
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography in Kids Intensive Care Decision Support - is Focused Echocardiography Superior to Pressure Derived Measurements at Predicting Fluid Responsiveness in Critically Ill Children?
- ClinicalTrials.gov ID
- NCT01821742
- Acronym / sponsor ID
- ECHOKIDS / IRAS ID 121440
- Conditions
- Fluid Responsiveness, Cardiac Output
- Keywords
- Shock, Fluid bolus, Cardiac output, Children in intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Apr 2013 (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.
A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU.
Detailed description
A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU. These parameters will be measured pre and post fluid bolus in children prescribed fluid bolus therapy for clinical indications on the PICU. Children will be classified as responders (>10% increase in cardiac output) and non responders (<10% increase). Appropriate statistical tests will be performed to determine the most useful predictor of an increase in cardiac output following a fluid bolus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children requiring fluid bolus on PICU | – | Other: Ultrasound cardiac output measurement |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Shocked children on PICU
Key inclusion criteria (1 listed)
- Any ventilated child requiring fluid bolus therapy on the PICU for clinical indications
Key exclusion criteria (2 listed)
- Arrythmia
- Intracardiac shunt
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 |
|---|---|---|
| Ultrasound cardiac output measurement | Other | Children requiring fluid bolus on PICU |
Primary outcome
Fluid responsiveness
Time frame: Immediate
10% increase in cardiac output following fluid bolus
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 8 Jul 2019.
- Results publication: PubMed 24306083McLean JRL, Inwald DP. The utility of stroke volume variability as a predictor of fluid responsiveness in critically ill children: a pilot study. Intensive Care Med. 2014 Feb;40(2):288-289. doi: 10.1007/s00134-013-3171-x. Epub 2013 Dec 5. No abstract available.
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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.
David Inwald, MB BChir principal investigator
Imperial College London
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 Fluid Responsiveness and Cardiac Output, run by Imperial College London at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 8 Jul 2019. 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 United Kingdom. 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?
Fluid responsiveness (time frame: Immediate). 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 NCT01821742, which also lists 1 linked publication.
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 Jul 2019.