Measuring the Metabolic Cost of Fever

NCT02939781 | Terminated Results

• 1 other identifier: 209010
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Child; Critical Illness; Fever

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Indirect calorimetry DEVICE

Indirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence

Febrile critically ill children

Eligibility Criteria

• Age: 0 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Critically ill children admitted on the intensive care unit at risk of developing fever

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

MeSH Terms

Conditions

Critical Illness; Fever

Interventions

Calorimetry, Indirect

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr Samiran Ray
• Organization: Great Ormond Street Hospital NHS Trust

samiran.ray@gosh.nhs.uk

4420274059200

Study Officials

• Mark J Peters, MBBCh PhD

  UCL Great Ormond Street Institute of Child Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 20, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: June 25, 2021
• Results First Posted: June 25, 2021

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share