Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT01173367
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years old
* Fever (two consecutive measurements ≥ 38.3°C at least 2 hours apart or a single temperature measurement ≥ 39.5°C)
* Admitted to ICU with an expected length of stay at least 48 hours related to critical illness
* Attending physician approval
Exclusion Criteria:
* Admission to ICU for support for specific procedure (e.g. endoscopy, acute dialysis, bronchoscopy)
* Acute brain injury due to any etiology
* Acute myocardial ischemia
* Documented hepatitis with elevated alanine aminotransferase (ALT) more than twice the upper limit of normal, or chronic hepatic failure (defined by evidence of cirrhosis on available imaging or known varices, ascites, hepatic encephalopathy, hepatorenal syndrome, and/or hepatocellular carcinoma)
* Hyperthermia syndromes (malignant hyperthermia, heat stroke, neuroleptic malignant syndrome, serotonin syndrome, or endocrine causes including thyrotoxicosis, pheochromocytoma, and adrenal crisis)
* Refractory shock with lactic acidosis \>4 mmol/L (at the time of screening for study enrollment) despite supportive therapy or need for paralytic treatment to reduce metabolic demand
* Requirement for use of anti-pyretic agents (acetaminophen or NSAIDs) for indications other than treatment of fever
* Receipt of anti-pyretic pharmacotherapy within 6-hours of expected study enrollment (650mg acetaminophen, 800mg ibuprofen, or 325mg acetylsalicylic acid)
* Contraindications to esophageal temperature monitoring
* Pregnancy (all women of child-bearing potential need to have a pregnancy test performed prior to enrollment)
* Time from onset of fever in the ICU to consideration for study enrollment is \> 12 hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01173367
Study Brief:
Protocol Section:
NCT01173367