Thermogard™ Efficacy Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Thermogard™ Efficacy Trial

Conditions
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Hypothermia, Burns

Intervention / Treatment
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* Device: Thermogard™
* Device: Standard central venous catheter


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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™<br>* Those who have a Thermogard™ central venous warming catheter placed prior to surgery<br>* Other names: Rewarming;|
| Active Comparator: B<br>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<br>* Those who have a standard central venous catheter placed prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambient room temperature |  | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the incidence, duration and severity of hypothermia, |  | Beginning of surgery to eight hours postoperative | 
| 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 |  | Beginning of surgery to eight hours postoperative | 
| Compare the incidence of foreshortened surgery due to refractory hypothermia defined as a persistent core body temperature less than 35.0 °C. |  | Intraoperative | 
| 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 |  | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Severe burns, Warming catheter, Thermogard™, Coagulopathy