HypothermiaNCT00822796
Thermogard™ Efficacy Trial
A study testing Thermogard™ and Standard central venous catheter in people with Hypothermia and Burns, run by Brooke Army Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypothermia, Burns
- What is being tested?
- Thermogard™ and Standard central venous catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
About this study
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.
Read the 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.
- Conditions
- Hypothermia, Burns
- Being tested
- Thermogard™, Standard central venous catheter
- Keywords
- Hypothermia, Severe burns, Warming catheter, Thermogard™, Coagulopathy
- Medical subject headings
- Hypothermia, Burns, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermogard™Device
Also called Rewarming
Those who have a Thermogard™ central venous warming catheter placed prior to surgery
Standard central venous catheterDevice
Those who have a standard central venous catheter placed prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Standard central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambient room temperature
Measured: Intraoperative
Secondary outcomes (4)
Compare the incidence, duration and severity of hypothermia,
Measured: 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
Measured: 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.
Measured: 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
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Difficulty in obtaining surrogate consent on critically ill subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Timothy F. Haley, Brooke Army Medical Center
- Investigators
- Timothy F. Haley, MD, Principal investigator, Brooke Army Medical CenterSteven E. Wolf, MD, Study director, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822796
- Sponsor's protocol ID
- I.2008.030
- Other IDs
- CIRO 2008235
- Status last verified
- Jul 2013
- First submitted
- 13 Jan 2009
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 3656464Robinson 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
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.
PubMed 9087467Kurz 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.
PubMed 8606715Doufas 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.
PubMed 14661656Weinberg AD. Hypothermia. Ann Emerg Med. 1993 Feb;22(2 Pt 2):370-7. doi: 10.1016/s0196-0644(05)80467-6.
PubMed 8434836Gore 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.
PubMed 9210551Soung 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.
PubMed 589543Wong 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.
PubMed 1433050El-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.
PubMed 10702459Hancock 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.
PubMed 12745975Koenders S, Struijs A, et al, Feasibility of an intravenous warming device to rewarm cardiac surgery patients. NJCC 2004;8:34.
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.
PubMed 19117092Willekes 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.
PubMed 16988294Arthurs 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.
PubMed 16647346
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermogard™ Efficacy Trial
- ClinicalTrials.gov ID
- NCT00822796
- Acronym / sponsor ID
- I.2008.030
- Conditions
- Hypothermia, Burns
- Keywords
- Hypothermia, Severe burns, Warming catheter, Thermogard™, Coagulopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in obtaining surrogate consent on critically ill subjects.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Thermogard™Burn patients with >20% TBSA burns scheduled to undergo debridement and grafting who will have placed the Thermogard™ central venous warming catheter by Alsius |
| B | Active comparator | Device: Standard central venous catheterBurn 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermogard™Also: RewarmingThose who have a Thermogard™ central venous warming catheter placed prior to surgery | Device | A |
| Standard central venous catheterThose who have a standard central venous catheter placed prior to surgery | Device | B |
Primary outcome
Ambient room temperature
Time frame: Intraoperative
4 secondary outcomes
Compare the incidence, duration and severity of hypothermia,
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Intraoperative
Results and safety
The study was stopped early (reason given: Difficulty in obtaining surrogate consent on critically ill subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
- Background: PubMed 3656464Jurkovich GJ, Greiser WB, Luterman A, Curreri PW. Hypothermia in trauma victims: an ominous predictor of survival. J Trauma. 1987 Sep;27(9):1019-24.
- BackgroundRobinson 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: PubMed 9087467Frank 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.
- Background: PubMed 8606715Kurz 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.
- Background: PubMed 14661656Doufas 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.
- Background: PubMed 8434836Weinberg AD. Hypothermia. Ann Emerg Med. 1993 Feb;22(2 Pt 2):370-7. doi: 10.1016/s0196-0644(05)80467-6.
- Background: PubMed 9210551Gore 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.
- Background: PubMed 589543Soung 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.
- Background: PubMed 1433050Wong 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.
- Background: PubMed 10702459El-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.
- Background: PubMed 12745975Hancock 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.
- BackgroundKoenders S, Struijs A, et al, Feasibility of an intravenous warming device to rewarm cardiac surgery patients. NJCC 2004;8:34.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy F. Haley, MD principal investigator
Brooke Army Medical Center
Steven E. Wolf, MD study director
US Army Institute of Surgical Research
Questions about this trial
What is this clinical trial studying?
A study testing Thermogard™ and Standard central venous catheter in people with Hypothermia and Burns, run by Brooke Army Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in obtaining surrogate consent on critically ill subjects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambient room temperature (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822796, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2013.