Thermogard™ Efficacy Trial

This study has been terminated.
(Difficulty in obtaining surrogate consent on critically ill subjects.)
Sponsor:
Information provided by (Responsible Party):
Timothy F. Haley, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00822796
First received: January 13, 2009
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine if the Thermogard™ central venous catheter can prevent hypothermia (defined as a core body temperature less then 36.0 °C) in severely burned patients who are undergoing surgery for debridement and grafting in the setting of reduced ambient room temperature.


Condition Intervention
Hypothermia
Burns
Device: Thermogard™
Device: Standard central venous catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thermogard™ Efficacy Trial

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Ambient room temperature [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare the incidence, duration and severity of hypothermia, [ Time Frame: Beginning of surgery to eight hours postoperative ] [ Designated as safety issue: Yes ]
  • Compare the need for perioperative blood and/or blood product transfusions as a function of the percent total body surface area (TBSA) excised and grafted during surgery [ Time Frame: Beginning of surgery to eight hours postoperative ] [ Designated as safety issue: Yes ]
  • Compare the incidence of foreshortened surgery due to refractory hypothermia defined as a persistent core body temperature less than 35.0 °C. [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
  • Compare the difference between skin/core body temperature and the ambient room temperature of those physicians and associate staff members providing care to burn patients in the operating room [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Burn patients with >20% TBSA burns scheduled to undergo debridement and grafting who will have placed the Thermogard™ central venous warming catheter by Alsius
Device: Thermogard™
Those who have a Thermogard™ central venous warming catheter placed prior to surgery
Other Name: Rewarming
Active Comparator: B
Burn patients with >20% TBSA burns scheduled to undergo debridement and grafting who will have placed a central venous catheter as a part of their routine burn management
Device: Standard central venous catheter
Those who have a standard central venous catheter placed prior to surgery

Detailed Description:

Hypothermia in the severely burned has been shown to disrupt coagulation, impair myocardial function, weaken the host immune response, delay wound healing and increase mortality.

Current methods available for preventing and reversing hypothermia include administering heated, humidified oxygen, infusing warmed intravenous fluids centrally, performing peritoneal dialysis with warmed fluid, undergoing extracorporeal blood warming with partial bypass, and markedly increasing the ambient room temperature. These methods are either limited in their effectiveness or are impractical and potentially dangerous. Furthermore, the practice of markedly increasing the ambient room temperature creates a hostile work environment for health care providers which may impact patient care.

The FDA has classified the Alsius Thermogard™ heat exchange catheter as a Class II devices under 21 C.F.R §§ 870.5900. It is used in various clinical applications for cooling patients but it has not been FDA-approved for use in warming burn patients. The Thermogard™ is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling catheter that is placed percutaneously in the patient. The catheter can be placed in the femoral vein (larger catheter with three heat exchange balloons) or the subclavian or jugular vein (smaller catheter with two heat exchange balloons).

Sterile saline is warmed (to a maximum temperature of 38 °C) in the external device and then pumped through the balloons coaxially mounted on the catheter, enabling direct warming of the blood. The catheter contains a temperature probe enabling a 'closed loop' temperature control system; the temperature is set at the desired level (the range of the device is 28-38°C, which may vary according to the installed software), after which the device warms the patient to this level by increasing or decreasing the temperature of the circulating saline. The core temperature is then maintained at the desired level for as long as the attending physician deems necessary. The catheter also has two ports for central venous access, which can be used to administer medication and/or for blood sampling.

The purpose of this study is to determine if the Thermogard™ central venous catheter can significantly impact the heat stress environment of the operating room by allowing severely burned patients to undergo surgery for debridement and grafting at lower ambient operating room temperatures when compared to control subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult males and non-pregnant females ages 18-70 with greater than 20% TBSA burns requiring excision and grafting and in need of a central venous catheter per ICU admission criteria.
  • Patient or patient's surrogate must be able to verbalize understanding and willingness to participate in the study and provide written informed consent

Exclusion Criteria:

  • Pregnancy. All females admitted to the burn ICU undergo routine serum hCG to determine pregnancy status. Those found to be pregnant will be excluded from entry into the study
  • Burn patients enrolled in recombinant Factor VII study due to the theoretical increased risk for clot formation
  • Basic and advanced enlisted trainees
  • Age greater than 70 years old due to increased mortality rate among those severely burned
  • Conditions which make placement of a central venous catheters a greater than normal risk (vascular anomalies, previous vascular surgery, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822796

Sponsors and Collaborators
Brooke Army Medical Center
Investigators
Principal Investigator: Timothy F. Haley, MD Brooke Army Medical Center
Study Director: Steven E. Wolf, MD US Army Institute of Surgical Research
  More Information

Publications:
Robinson S, Katariya K, et al. Perioperative temperature management: Roundtable discussion identifies need to avoid hypothermia. Minutes from the Anesthesia Patient Safety Foundation. 11 June 2005; Louisville, KY
Koenders S, Struijs A, et al, Feasibility of an intravenous warming device to rewarm cardiac surgery patients. NJCC 2004;8:34.
Koukoulitisios GV Stathopoulous GT, et al.Using an intravascular cooling device to reverse refractory burn-associated hypothermia. Int Care Med 2006;32 (Sup 13):S29.

Responsible Party: Timothy F. Haley, Division Surgeon, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT00822796     History of Changes
Other Study ID Numbers: I.2008.030, CIRO 2008235
Study First Received: January 13, 2009
Last Updated: July 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Hypothermia
Severe burns
Warming catheter
Thermogard™
Coagulopathy

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014