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Assessment of the safety and feasibility of administering anti-pyretic therapy in critically ill adults: study protocol of a randomized trial
BACKGROUND: Fever is one of the most commonly observed abnormal signs in patients with critical illness. However, there is a paucity of evidence to guide the management of febrile patients without acute brain injury and little is known about the biologic response to treatment of fever. As such, obse...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3327640/ https://www.ncbi.nlm.nih.gov/pubmed/22420838 http://dx.doi.org/10.1186/1756-0500-5-147 |
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author | Niven, Daniel J Léger, Caroline Kubes, Paul Stelfox, H Tom Laupland, Kevin B |
author_facet | Niven, Daniel J Léger, Caroline Kubes, Paul Stelfox, H Tom Laupland, Kevin B |
author_sort | Niven, Daniel J |
collection | PubMed |
description | BACKGROUND: Fever is one of the most commonly observed abnormal signs in patients with critical illness. However, there is a paucity of evidence to guide the management of febrile patients without acute brain injury and little is known about the biologic response to treatment of fever. As such, observational studies suggest that the treatment of fever is inconsistent. This pilot clinical trial will assess the safety and feasibility of treating febrile critically ill adult patients with an aggressive versus a permissive temperature control strategy. The biologic response to these two different temperature control strategies will also be assessed through analysis of a panel of inflammatory mediators. FINDINGS: The study population will include febrile adult patients admitted to one of two general medical-surgical intensive care units (ICUs) in Calgary, Alberta, Canada. Patients will be randomized to either an aggressive or permissive fever treatment strategy. The aggressive group will receive acetaminophen 650 mg enterally every 6 hours upon reaching a temperature ≥ 38.3°C and external cooling will be initiated for temperatures ≥ 39.5°C, whereas the permissive group will receive acetaminophen 650 mg every 6 hours upon reaching a temperature ≥ 40.0°C and external cooling for temperatures ≥ 40.5°C. The study will take place over 12 months with the goal of enrolling 120 patients. The primary outcome will be 28-day mortality after study enrolment, with secondary outcomes that will include markers of feasibility (e.g. the enrolment rate, and the number of protocol violations), and levels of select inflammatory and anti-inflammatory mediators. DISCUSSION: Results from this study will lead to a better understanding of the inflammatory effects of anti-pyretic therapy and will evaluate the feasibility of a future clinical trial to establish the best treatment of fever observed in nearly one half of patients admitted to adult ICUs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01173367 |
format | Online Article Text |
id | pubmed-3327640 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-33276402012-04-17 Assessment of the safety and feasibility of administering anti-pyretic therapy in critically ill adults: study protocol of a randomized trial Niven, Daniel J Léger, Caroline Kubes, Paul Stelfox, H Tom Laupland, Kevin B BMC Res Notes Project Note BACKGROUND: Fever is one of the most commonly observed abnormal signs in patients with critical illness. However, there is a paucity of evidence to guide the management of febrile patients without acute brain injury and little is known about the biologic response to treatment of fever. As such, observational studies suggest that the treatment of fever is inconsistent. This pilot clinical trial will assess the safety and feasibility of treating febrile critically ill adult patients with an aggressive versus a permissive temperature control strategy. The biologic response to these two different temperature control strategies will also be assessed through analysis of a panel of inflammatory mediators. FINDINGS: The study population will include febrile adult patients admitted to one of two general medical-surgical intensive care units (ICUs) in Calgary, Alberta, Canada. Patients will be randomized to either an aggressive or permissive fever treatment strategy. The aggressive group will receive acetaminophen 650 mg enterally every 6 hours upon reaching a temperature ≥ 38.3°C and external cooling will be initiated for temperatures ≥ 39.5°C, whereas the permissive group will receive acetaminophen 650 mg every 6 hours upon reaching a temperature ≥ 40.0°C and external cooling for temperatures ≥ 40.5°C. The study will take place over 12 months with the goal of enrolling 120 patients. The primary outcome will be 28-day mortality after study enrolment, with secondary outcomes that will include markers of feasibility (e.g. the enrolment rate, and the number of protocol violations), and levels of select inflammatory and anti-inflammatory mediators. DISCUSSION: Results from this study will lead to a better understanding of the inflammatory effects of anti-pyretic therapy and will evaluate the feasibility of a future clinical trial to establish the best treatment of fever observed in nearly one half of patients admitted to adult ICUs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01173367 BioMed Central 2012-03-16 /pmc/articles/PMC3327640/ /pubmed/22420838 http://dx.doi.org/10.1186/1756-0500-5-147 Text en Copyright ©2012 Niven et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Project Note Niven, Daniel J Léger, Caroline Kubes, Paul Stelfox, H Tom Laupland, Kevin B Assessment of the safety and feasibility of administering anti-pyretic therapy in critically ill adults: study protocol of a randomized trial |
title | Assessment of the safety and feasibility of administering anti-pyretic therapy in critically ill adults: study protocol of a randomized trial |
title_full | Assessment of the safety and feasibility of administering anti-pyretic therapy in critically ill adults: study protocol of a randomized trial |
title_fullStr | Assessment of the safety and feasibility of administering anti-pyretic therapy in critically ill adults: study protocol of a randomized trial |
title_full_unstemmed | Assessment of the safety and feasibility of administering anti-pyretic therapy in critically ill adults: study protocol of a randomized trial |
title_short | Assessment of the safety and feasibility of administering anti-pyretic therapy in critically ill adults: study protocol of a randomized trial |
title_sort | assessment of the safety and feasibility of administering anti-pyretic therapy in critically ill adults: study protocol of a randomized trial |
topic | Project Note |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3327640/ https://www.ncbi.nlm.nih.gov/pubmed/22420838 http://dx.doi.org/10.1186/1756-0500-5-147 |
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