Thermogard™ Efficacy Trial

NCT00822796 | Terminated DMC

• 2 other identifiers: I.2008.030CIRO 2008235
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypothermia; Burns

Keywords

Hypothermia; Severe burns; Warming catheter; Thermogard™; Coagulopathy

Outcome Measures

Primary Outcomes (1)

• Ambient room temperature

  Intraoperative

Secondary Outcomes (4)

• 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

Study Arms (2)

A

EXPERIMENTAL

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™

B

ACTIVE COMPARATOR

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

Interventions

Thermogard™ DEVICE

Those who have a Thermogard™ central venous warming catheter placed prior to surgery

Also known as: Rewarming

A

Standard central venous catheter DEVICE

Those who have a standard central venous catheter placed prior to surgery

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Related Publications (15)

• 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.

  PMID: 3656464 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 9087467 BACKGROUND

• 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. doi: 10.1056/NEJM199605093341901.

  PMID: 8606715 BACKGROUND

• Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. doi: 10.1016/s1521-6896(03)00052-1.

  PMID: 14661656 BACKGROUND

• Weinberg AD. Hypothermia. Ann Emerg Med. 1993 Feb;22(2 Pt 2):370-7. doi: 10.1016/s0196-0644(05)80467-6.

  PMID: 8434836 BACKGROUND

• Gore DC, Beaston J. Infusion of hot crystalloid during operative burn wound debridement. J Trauma. 1997 Jun;42(6):1112-5. doi: 10.1097/00005373-199706000-00022.

  PMID: 9210551 BACKGROUND

• 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. No abstract available.

  PMID: 589543 BACKGROUND

• 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. doi: 10.1177/014107689208501021. No abstract available.

  PMID: 1433050 BACKGROUND

• El-Gamal N, Elkassabany 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. doi: 10.1097/00000539-200003000-00034.

  PMID: 10702459 BACKGROUND

• 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. doi: 10.1080/0265673021000054630.

  PMID: 12745975 BACKGROUND

• Koenders S, Struijs A, et al, Feasibility of an intravenous warming device to rewarm cardiac surgery patients. NJCC 2004;8:34.

  BACKGROUND

• Karabinis A, Mandila C, Koukoulitsios G, Dounis G, Tsoutsos D. Using an intravascular device to reverse refractory burn-associated hypothermia. Anaesth Intensive Care. 2008 Nov;36(6):918-9. No abstract available.

  PMID: 19117092 BACKGROUND

• 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. doi: 10.1136/emj.2006.035360.

  PMID: 16988294 BACKGROUND

• 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. doi: 10.1016/j.amjsurg.2006.02.010.

  PMID: 16647346 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Burns; Hemostatic Disorders

Interventions

Rewarming

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Timothy F. Haley, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

• Steven E. Wolf, MD

  US Army Institute of Surgical Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Surgeon

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: September 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 24, 2013

Record last verified: 2013-07