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Completed

NCT Number: NCT02706275

Pilot Trial of External Warming in Septic Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Primary outcomes

  1. Monocyte human leukocyte antigen (mHLA-DR) expression

    Time frame: 48 hours hours following the start of the intervention period

Secondary outcomes

  1. Interferon (IFN)-gamma production

    Time frame: 48 hours following the start of the intervention period

  2. Number of patients who acquire nosocomial infections

    Time frame: 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

  3. Mortality

    Time frame: 28 days

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

    Time frame: Through study completion, 2 years

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Pilot Randomized Trial of External Warming in Critically Ill Adult Septic Patients

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2016
Registry last updated
Apr 28, 2020

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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