Pilot Trial of External Warming in Septic Patients

Not Applicable

Completed

• Conditions: Sepsis

• Registration Number: NCT02706275
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to determine whether externally warming critically ill afebrile adult septic patients will improve indices of immune function and/or clinical outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Primary Completion: 2019-05-12
• Study Completion: 2019-05-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Admitted to a surgical or medical intensive care unit
• Age greater than 18 years
• Diagnosis of sepsis within 24 hours of enrollment
• Requirement for mechanical ventilation with expected duration of mechanical ventilation > 48 hours
• Goal Richmond Agitation Sedation Scale (RASS) < 0
• Maximum baseline temperature (within previous 24 hours) < 38.3°C

Exclusion Criteria

• Treatment with chemotherapy within 6 months of enrollment
• Treatment with corticosteroids at a dose > 300 mg/day hydrocortisone (or equivalent)
• History of solid organ transplant on any immunosuppression medication
• History of immunological disease
• History of chronic infection with hepatitis B or C virus
• History of acute stroke, acute coronary syndrome, or severe head injury requiring osmotic therapy within 7 days prior to enrollment
• History of multiple sclerosis
• Contraindications to both bladder or esophageal core temperature monitors or to forced air warming blankets
• Moribund status
• Sepsis without source control

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Monocyte human leukocyte antigen (mHLA-DR) expression	48 hours hours following the start of the intervention period

Secondary Outcome Measures

Name	Time	Method
Number of patients who acquire nosocomial infections	30 days after diagnosis of sepsis	Number of patients who develop a nosocomial infection (defined as a new infection diagnosed greater than 48 hours after the original sepsis diagnosis) within 30 days of the sepsis diagnosis
Number of patients in whom the intervention is stopped early secondary to hemodynamic changes related to the intervention	Through study completion, 2 years
Interferon (IFN)-gamma production	48 hours following the start of the intervention period
Mortality	28 days

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States