Pilot Trial of External Warming in Septic Patients

NCT02706275 | Completed DMC

• 1 other identifier: 201512121
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Monocyte human leukocyte antigen (mHLA-DR) expression

  48 hours hours following the start of the intervention period

Secondary Outcomes (4)

• Interferon (IFN)-gamma production

  48 hours following the start of the intervention period

• Number of patients who acquire nosocomial infections

  30 days after diagnosis of sepsis

• Mortality

  28 days

• Number of patients in whom the intervention is stopped early secondary to hemodynamic changes related to the intervention

  Through study completion, 2 years

Study Arms (2)

Warming Group

EXPERIMENTAL

External warming via forced air warming

Other: External warming

Control Group

NO INTERVENTION

Standard of care body temperature management

Interventions

External warming OTHER

External warming via forced air warming to a goal body temperature 1.5°C greater than the baseline minimum temperature (within previous 24 hours) for 48 hours

Warming Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Drewry AM, Mohr NM, Ablordeppey EA, Dalton CM, Doctor RJ, Fuller BM, Kollef MH, Hotchkiss RS. Therapeutic Hyperthermia Is Associated With Improved Survival in Afebrile Critically Ill Patients With Sepsis: A Pilot Randomized Trial. Crit Care Med. 2022 Jun 1;50(6):924-934. doi: 10.1097/CCM.0000000000005470. Epub 2022 Feb 7.

  PMID: 35120040 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 11, 2016
• Study Start: March 1, 2016
• Primary Completion: May 12, 2019
• Study Completion: May 12, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

US (1)