Thermogard™ Efficacy Trial

Burns Clinical Trial

Official title:

Thermogard™ Efficacy Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00822796
• Other study ID #: I.2008.030
• Secondary ID: CIRO 2008235
• Status: Terminated
• Phase: N/A
• First received: January 13, 2009
• Last updated: July 22, 2013
• Start date: September 2008
• Est. completion date: October 2009

Study information

• Verified date: July 2013
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Hypothermia

Intervention

Device:
• Thermogard™
Those who have a Thermogard™ central venous warming catheter placed prior to surgery
• Standard central venous catheter
Those who have a standard central venous catheter placed prior to surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

References & Publications (15)

Arthurs Z, Cuadrado D, Beekley A, Grathwohl K, Perkins J, Rush R, Sebesta J. The impact of hypothermia on trauma care at the 31st combat support hospital. Am J Surg. 2006 May;191(5):610-4. — View Citation

Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. Review. — View Citation

El-Gamal N, El-Kassabany N, Frank SM, Amar R, Khabar HA, El-Rahmany HK, Okasha AS. Age-related thermoregulatory differences in a warm operating room environment (approximately 26 degrees C). Anesth Analg. 2000 Mar;90(3):694-8. — View Citation

Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34. — View Citation

Gore DC, Beaston J. Infusion of hot crystalloid during operative burn wound debridement. J Trauma. 1997 Jun;42(6):1112-5. — View Citation

Hancock PA, Vasmatzidis I. Effects of heat stress on cognitive performance: the current state of knowledge. Int J Hyperthermia. 2003 May-Jun;19(3):355-72. Review. — View Citation

Jurkovich GJ, Greiser WB, Luterman A, Curreri PW. Hypothermia in trauma victims: an ominous predictor of survival. J Trauma. 1987 Sep;27(9):1019-24. — View Citation

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.

Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. — View Citation

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

Soung LS, Swank L, Ing TS, Said RA, Goldman JW, Perez J, Geis WP. Treatment of accidental hypothermia with peritoneal dialysis. Can Med Assoc J. 1977 Dec 17;117(12):1415-6. — View Citation

Weinberg AD. Hypothermia. Ann Emerg Med. 1993 Feb;22(2 Pt 2):370-7. Review. — View Citation

Willekes T, Naunheim R, Lasater M. A novel method of intravascular temperature modulation to treat severe hypothermia. Emerg Med J. 2006 Oct;23(10):e56. — View Citation

Wong PS, Pugsley WB. Partial cardiopulmonary bypass for the treatment of profound accidental hypothermic circulatory collapse. J R Soc Med. 1992 Oct;85(10):640. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambient room temperature		Intraoperative	Yes
Secondary	Compare the incidence, duration and severity of hypothermia,		Beginning of surgery to eight hours postoperative	Yes
Secondary	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	Yes
Secondary	Compare the incidence of foreshortened surgery due to refractory hypothermia defined as a persistent core body temperature less than 35.0 °C.		Intraoperative	Yes
Secondary	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	No