Measuring the Metabolic Cost of Fever

NCT ID: NCT02939781

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-11-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: DEVICE

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

Interventions

Indirect calorimetry

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark J Peters, MBBCh PhD

Role: PRINCIPAL_INVESTIGATOR

UCL Great Ormond Street Institute of Child Health

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

209010

Identifier Type: -

Identifier Source: org_study_id