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Completed

NCT Number: NCT00940654

The Fever and Antipyretic in Critically Illness Evaluation Study

The purpose of this multination multicenter observational study is to determine the impact of fever and antipyretic on outcomes in critically ill patients.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Japanese Society of Intensive Care Medicine, Bunkyo-ku, Tokyo, Japan

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About this study

Fever is common in critically ill patients.Antipyretic therapy for fever is routinely performed in intensive care.There are studies to assess the relationship between fever and mortality in non-neurological ICU. However, all of them did not have any information of antipyretic therapy. There are two small, single center RCT, which suggested a potential risk for antipyretic therapy. Thus, a large RCT might be ethically difficult.

It is unfortunate that there is not enough information on how the investigators should control body temperature in non-neurological critically ill patients, because fever is a very common physiological abnormality in this cohort. From the beginning, it would, therefore, be desirable to understand several aspects of fever and antipyretic therapy in ICU patients, as 1)How often fever occurs in our ICUs, 2)To what degree fever is independently associated with mortality?, 3)How often antipyretic therapy is prescribed?, 4)How effectively antipyretic can decrease temperature?, 5)How different is lowering temperature with medications compared with cooling?, 6)To what degree antipyretic is independently associated with mortality?

Thus, the investigators plan to address these questions by conducting a multi-national multi-center prospective observational trial, named "The Fever and Antipyretic in Critically illness evaluation study" (The FACE study)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult non-neurological critically ill patients (20 years old or older).
  • ICU patients expected to require intensive care for more than 48 hour.

Exclusion criteria

  • Patients with brain injury (suspected or proven)

Treatment and study plan

Antipyretic therapy

Other

External cooling;Internal cooling;Non steroid anti inflammatory drugs; Acetaminophen; Steroid

Other names: External cooling, Internal cooling, Non steroid anti inflammatory drugs, Acetaminophen, Steroid, Others

Primary outcomes

  1. 28 days mortality

    Time frame: 28days after ICU admission

Secondary outcomes

  1. ICU free days at 28 days

    Time frame: 28 days after ICU admission

  2. Hospital free days at 28 days

    Time frame: 28 days

  3. Ventilator free days at 28 days

    Time frame: 28 days at ICU admission

  4. Renal replacement therapy free days at 28 days

    Time frame: 28 days at ICU admission

Sponsors and collaborators

Lead sponsor

Japanese Society of Intensive Care Medicine

Other

Registry information

Acronym: FACE

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 16, 2009
Registry last updated
May 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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