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Measuring the Metabolic Cost of Fever (IGUANA)

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ClinicalTrials.gov Identifier: NCT02939781
Recruitment Status : Unknown
Verified October 2016 by Great Ormond Street Hospital for Children NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief 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. 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.


Condition or disease Intervention/treatment
Child Critical Illness Fever Device: Indirect calorimetry

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Energy Expenditure Before and After Fever in Critically Ill Children
Study Start Date : November 2016
Estimated Primary Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Group/Cohort Intervention/treatment
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.
Device: Indirect calorimetry
Indirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence




Primary Outcome Measures :
  1. Change in energy expenditure (in kcal) before, during and after fever [ 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.



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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill children admitted on the intensive care unit at risk of developing fever
Criteria

Inclusion Criteria:

- all children on the paediatric intensive care unit at Great Ormond Street Hospital who

  1. are likely to or have developed a fever (suspected infection, following trauma, post major surgery)
  2. are over 10kg (approx 1 year of age)
  3. are invasively ventilated

Exclusion Criteria:

- Children who

  1. have a brain injury, where active temperature control may be instituted
  2. patients post cardiac surgery
  3. patient with or at risk of cardiac arrhythmias
  4. patients post cardiac arrest
  5. patient with refractory status epilepticus
  6. children with a greater than 5% leak around the endotracheal tube
  7. children with a fraction of inspired oxygen >0.6

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939781


Contacts
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Contact: Samiran Ray, MBBChir MA 02074059200 ext 0032 samiran.ray@gosh.nhs.uk

Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
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Principal Investigator: Mark J Peters, MBBCh PhD UCL Great Ormond Street Institute of Child Health

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02939781     History of Changes
Other Study ID Numbers: 209010
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Fever
Critical Illness
Body Temperature Changes
Signs and Symptoms
Disease Attributes
Pathologic Processes