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Hypothermia clinical trials

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NCT ID: NCT00347477 Completed - Cardiac Arrest Clinical Trials

Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest

Start date: September 2005
Phase: Phase 3
Study type: Interventional

Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a significant way. However hypothermia also causes leak of fluid into the surrounding tissue. This edema could lead to damage to the same tissue, not beneficial for the patients. We therefore try to evaluate if hyperosmolar, hyperoncotic fluid as an alternative to std. treatment (NaCl/RA)could affect the edema in a positive way, and result to a better outcome neurological for the patients.

NCT ID: NCT00334360 Completed - Hypothermia Clinical Trials

Dexmed/Buspirone Synergism on Shivering

Start date: September 2004
Phase: Phase 4
Study type: Interventional

The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia. The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration. Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. Lactated Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. Heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.

NCT ID: NCT00329563 Completed - Cardiac Arrest Clinical Trials

Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Start date: November 2004
Phase: Phase 1/Phase 2
Study type: Interventional

The overall goal of this study is to determine the feasibility of initiating hypothermia in cardiac arrest patients as soon as possible in the field. In this pilot study we will randomize 125 patients after return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC. The primary objectives of this study will be to determine whether temperature of 33-34oC can be achieved and maintained using this strategy. The primary outcome measures will include: temperature changes of the patients at time of admission to the hospital. Secondary analysis will include determining if the proportion of patients discharged from the hospital is increased in the group receiving hypothermia. If this initial pilot study can demonstrate feasibility in achieving and maintaining hypothermia, a larger randomized clinical trial to test the hypothesis that hypothermia initiation in the field will increase the proportion of patients surviving following cardiac arrest will be planned.

NCT ID: NCT00299416 Completed - Clinical trials for Acute Ischemic Stroke

Caffeinol Hypothermia Protocol

Start date: February 2003
Phase: Phase 1/Phase 2
Study type: Interventional

Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2 glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two hour while being cooled to 34.5 C.

NCT ID: NCT00283088 Completed - Stroke Clinical Trials

Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke

Start date: October 2003
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to evaluate if it is safe to use tissue plasminogen activator (tPA) within 6 hours of stroke onset when combined with hypothermia.

NCT ID: NCT00282373 Completed - Cardiac Arrest Clinical Trials

Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients

Start date: November 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of this study are to determine the safety and feasibility of inducing mild hypothermia using a non-invasive thermoregulatory device, the Medivance Arctic Sun Temperature Management System, in patients resuscitated after cardiac arrest.

NCT ID: NCT00282269 Completed - Clinical trials for Traumatic Brain Injury

Hypothermia in Traumatic Brain Injury in Children (HiTBIC)

Start date: November 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is: - To determine the safety and feasibility of performing an international multi-centre randomized control trial of early and prolonged hypothermia to improve outcome in children with severe traumatic brain injury (TBI). - To determine whether in children with severe traumatic brain injury, prolonged initial hypothermia (minimum 72 hours at 32-33 degrees) improves the proportion of good outcomes 12 months after injury when compared to initial normothermia (36-37 degrees).

NCT ID: NCT00264056 Recruiting - Clinical trials for Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases

Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases

Start date: December 2005
Phase: N/A
Study type: Interventional

The incidence of malignant melanoma continues to rise throughout the world. Approximately 12 in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is often very aggressive since it may spread both through the lymphatic system and the bloodstream at an early stage of disease. While treatment of localized disease is mostly surgical, in patients with extensive disease, prognosis remains poor; the primary standard therapy of metastastic disease comprises dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or BCNU. The duration of response to systemic chemotherapy is generally short and so far, no standard second-line treatment has been established. To study the potential additional therapeutic effects of regional hyperthermia in advanced malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases, in the present trial, we sought to compine local hyperthermia with concomitant systemic second-line chemotherapy.

NCT ID: NCT00231699 Completed - Child Clinical Trials

A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton and Plastic.

Start date: January 2004
Phase: N/A
Study type: Interventional

Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing general anesthesia is very important. However, there is very little information about effectiveness of various insulating materials used in the operating room. Objective: To compare the effectiveness of cotton and plastic for prevent intraoperative hypothermia in pediatric patients.

NCT ID: NCT00222742 Terminated - Clinical trials for Traumatic Brain Injury

Hypothermia in Children After Trauma

Start date: November 2007
Phase: Phase 3
Study type: Interventional

The primary hypothesis for this application for a multicenter phase III randomized clinical trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).