ChildIGUANANCT02939781
Measuring the Metabolic Cost of Fever
An observational study of Child and Critical Illness, run by Great Ormond Street Hospital for Children NHS Foundation Trust.
Trial summary
Fever is part of the body's immune response, often triggered by infection. Fever is commonly treated with medicines such as paracetamol, mainly because people feel unwell with fever. Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Child, Critical Illness, Fever
- What is being tested?
- Indirect calorimetry
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2018
- Phase
- Observational
- 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 0 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Critically ill children admitted on the intensive care unit at risk of developing fever
Who may be able to join
- all children on the paediatric intensive care unit at Great Ormond Street Hospital who
- are likely to or have developed a fever (suspected infection, following trauma, post major surgery)
- are over 10kg (approx 1 year of age)
- are invasively ventilated
Who cannot join
- Children who
- have a brain injury, where active temperature control may be instituted
- patients post cardiac surgery
- patient with or at risk of cardiac arrhythmias
- patients post cardiac arrest
- patient with refractory status epilepticus
- children with a greater than 5% leak around the endotracheal tube
- children with a fraction of inspired oxygen >0.6
About this study
Official title: Measuring Energy Expenditure Before and After Fever in Critically Ill Children
Fever is part of the body's immune response, often triggered by infection. Fever is commonly treated with medicines such as paracetamol, mainly because people feel unwell with fever. However fever does have a role in fighting infection: it enables the rest of the immune system to function more efficiently, and may directly stop bacteria and viruses from multiplying. In most cases however treating fever does not matter because the rest of the immune system can cope well enough to fight the infection (with or without additional treatment, like antibiotics).
In critically ill patients however any advantage in the fight against infection may be crucial. In a large observational study of adult patients in the intensive care unit, patients who developed an early fever with temperature between 38.5-39.5 degrees C fared relatively better than patients who were colder. So it is possible that in critical illness fever may be beneficial. However in critical illness the body does have limited energy resources. In order to raise the body temperature energy is required. However the investigators do not know how much energy is required to generate a fever in critically ill children. This study will aim to try and measure the energy required to generate a fever in a critically ill child. The investigators will measure energy expenditure directly in children admitted to the intensive care unit by measuring the levels of oxygen and carbon dioxide they breathe in and out (a method called indirect calorimetry). This will enable the investigators to judge whether the benefits of a fever can be justified by the energy costs in the energy depleted state that is critical illness.
- Conditions
- Child, Critical Illness, Fever
- Being tested
- Indirect calorimetry
- Medical subject headings
- Critical Illness, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect calorimetryDevice
Indirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence
| Study group | Role | What they receive |
|---|---|---|
| Febrile critically ill children | Children above 10kg admitted to the paediatric intensive care unit at Great Ormond Street Hospital who are mechanically ventilated and have a high likelihood of developing a fever. Energy expenditure will be measured using indirect calorimetry at baseline, and continuously during fever, until fever subsides. Receives: Device: Indirect calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Energy Expenditure Per Degree Celsius During Fever and Defervescence
Children at risk of fever will have energy expenditure measured by indirect calorimetry at baseline, when the develop a fever, and continuously until fever dehisces. Change in energy expenditure during fever to be calculated as difference in energy expenditure at the maximum temperature minus the energy expenditure at baseline, divided by the difference in temperature. Change in energy expenditure during defervescence to be calculated as difference in energy expenditure at the maximum temperature and the lowest temperature following the fall in temperature, divided by the difference in temperature.
Both will also be expressed as a % of the starting energy expenditure (i.e. from baseline for change during fever, from maximum temperature during defervescence)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionNov 2018
Why it stopped: Unable to recruit to protocol
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 ChildStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark J Peters, MBBCh PhD, Principal investigator, UCL Great Ormond Street Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939781
- Sponsor's protocol ID
- 209010
- Acronym
- IGUANA
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 25 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Energy Expenditure Before and After Fever in Critically Ill Children
- ClinicalTrials.gov ID
- NCT02939781
- Acronym / sponsor ID
- IGUANA / 209010
- Conditions
- Child, Critical Illness, Fever
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit to protocol
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Posted 25 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fever is part of the body's immune response, often triggered by infection. Fever is commonly treated with medicines such as paracetamol, mainly because people feel unwell with fever. However fever does have a role in fighting infection: it enables the rest of the immune system to function more efficiently, and may directly stop bacteria and viruses from multiplying. In most cases however treating fever does not matter because the rest of the immune system can cope well enough to fight the infection (with or without additional treatment, like antibiotics).
In critically ill patients however any advantage in the fight against infection may be crucial. In a large observational study of adult patients in the intensive care unit, patients who developed an early fever with temperature between 38.5-39.5 degrees C fared relatively better than patients who were colder. So it is possible that in critical illness fever may be beneficial. However in critical illness the body does have limited energy resources. In order to raise the body temperature energy is required. However the investigators do not know how much energy is required to generate a fever in critically ill children. This study will aim to try and measure the energy required to generate a fever in a critically ill child. The investigators will measure energy expenditure directly in children admitted to the intensive care unit by measuring the levels of oxygen and carbon dioxide they breathe in and out (a method called indirect calorimetry). This will enable the investigators to judge whether the benefits of a fever can be justified by the energy costs in the energy depleted state that is critical illness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Febrile critically ill children | – | Device: Indirect calorimetryChildren above 10kg admitted to the paediatric intensive care unit at Great Ormond Street Hospital who are mechanically ventilated and have a high likelihood of developing a fever. Energy expenditure will be measured using indirect calorimetry at baseline, and continuously during fever, until fever subsides. |
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Critically ill children admitted on the intensive care unit at risk of developing fever
Key inclusion criteria (4 listed)
- all children on the paediatric intensive care unit at Great Ormond Street Hospital who
- are likely to or have developed a fever (suspected infection, following trauma, post major surgery)
- are over 10kg (approx 1 year of age)
- are invasively ventilated
Key exclusion criteria (8 listed)
- Children who
- have a brain injury, where active temperature control may be instituted
- patients post cardiac surgery
- patient with or at risk of cardiac arrhythmias
- patients post cardiac arrest
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 |
|---|---|---|
| Indirect calorimetryIndirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence | Device | Febrile critically ill children |
Primary outcome
Percentage Change in Energy Expenditure Per Degree Celsius During Fever and Defervescence
Time frame: 6 hours
Children at risk of fever will have energy expenditure measured by indirect calorimetry at baseline, when the develop a fever, and continuously until fever dehisces. Change in energy expenditure during fever to be calculated as difference in energy expenditure at the maximum temperature minus the energy expenditure at baseline, divided by the difference in temperature. Change in energy expenditure during defervescence to be calculated as difference in energy expenditure at the maximum temperature and the lowest temperature following the fall in temperature, divided by the difference in temperature. Both will also be expressed as a % of the starting energy expenditure (i.e. from baseline for change during fever, from maximum temperature during defervescence)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mark J Peters, MBBCh PhD principal investigator
UCL Great Ormond Street Institute of Child Health
Questions about this trial
What is this clinical trial studying?
An observational study of Child and Critical Illness, run by Great Ormond Street Hospital for Children NHS Foundation Trust.
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 4 inclusion and 8 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 25 Jun 2021. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2021). 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?
Percentage Change in Energy Expenditure Per Degree Celsius During Fever and Defervescence (time frame: 6 hours). 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 25 Jun 2021.