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Unable to recruit to protocol
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indirect calorimetry | Device | Indirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 hours |
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Inclusion Criteria:
- all children on the paediatric intensive care unit at Great Ormond Street Hospital who
Exclusion Criteria:
- Children who
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Critically ill children admitted on the intensive care unit at risk of developing fever
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Peters, MBBCh PhD | UCL Great Ormond Street Institute of Child Health | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Critically Ill Children With or Likely to Have Fever | 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. Indirect calorimetry: Indirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Indirect calorimetry: Indirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Only one patient had a calorimetry measurement at baseline followed by a measurement during fever and two patients had measurements during fever, followed by fall in temperature. | Posted | Mean | Standard Deviation | percentage change | 6 hours |
|
Adverse event data was collected till discharge from the paediatric intensive care unit. Typically this was 7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Critically Ill Children With or Likely to Have Fever | All Critically ill children with or likely to have fever who had calorimetry measurement |
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Only one patient had a calorimetry measurement at baseline followed by a measurement during fever and two patients had measurements during fever and defervescence thereafter. The hypothesis that energy expenditure increases by 10% from baseline during fever could not be accurately tested.
Recruitment was difficult because fever in ICU occurs early in admission when patients at their least stable enough for calorimetry. When stabilised, fever becomes less likely despite prior history.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Samiran Ray | Great Ormond Street Hospital NHS Trust | 4420274059200 | 8213 | samiran.ray@gosh.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2016 | Feb 8, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2016 | Feb 8, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D005334 | Fever |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
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| ID | Term |
|---|---|
| D002153 | Calorimetry, Indirect |
| ID | Term |
|---|---|
| D002151 | Calorimetry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| Height | Median | Inter-Quartile Range | centimetres |
|
| OG000 | Change in Energy Expenditure During Fever | Children who had rise in temperature during Calorimetry measurement |
| OG001 | Change in Energy Expenditure During Fever Defervescence | Children who had a fall in temperature from a fever grade temperature (>=38C) during calorimetry |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D012816 | Signs and Symptoms |