Trial Outcomes & Findings for Measuring the Metabolic Cost of Fever (NCT NCT02939781)

NCT ID: NCT02939781

Last Updated: 2021-06-25

Results Overview

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)

• Recruitment status: TERMINATED
• Target enrollment: 12 participants
• Primary outcome timeframe: 6 hours
• Results posted on: 2021-06-25

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	12
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	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
Overall Study Protocol Violation	8
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Measuring the Metabolic Cost of Fever

Baseline characteristics by cohort

Measure	Febrile Critically Ill Children n=12 Participants 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
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	3.7 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants
Weight	16.9 kilograms n=5 Participants
Height	106 centimetres n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: 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.

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)

Outcome measures

Measure	Change in Energy Expenditure During Fever n=3 Participants Children who had rise in temperature during Calorimetry measurement	Change in Energy Expenditure During Fever Defervescence n=2 Participants Children who had a fall in temperature from a fever grade temperature (\>=38C) during calorimetry
Percentage Change in Energy Expenditure Per Degree Celsius During Fever and Defervescence	18.8 percentage change Standard Deviation 6.8	6.3 percentage change Standard Deviation 6.2

Adverse Events

Critically Ill Children With or Likely to Have Fever

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Samiran Ray

Great Ormond Street Hospital NHS Trust

Phone: 4420274059200

Email: samiran.ray@gosh.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place