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Hypothermia clinical trials

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NCT ID: NCT00965016 Recruiting - Clinical trials for Out-of-Hospital Cardiac Arrest

Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation.

Start date: January 2009
Phase: Phase 0
Study type: Interventional

Background: Cardiopulmonary resuscitation (CPR) with closed-chest cardiac massage has been shown that survival to discharge rate is poor. Attempt to increase success, some aggressive methods such as extracorporeal membrane oxygenation (ECMO) has been used (also known as extracorporeal cardiopulmonary resuscitation, ECPR). Otherwise, anoxic brain injury is another issue after CPR. In recent years, some randomized prospective controlled trials of induced hypothermia (IH) to 33℃ for 12 to 24 hours has been demonstrated to significantly improve outcome in cardiac arrest patients. Because ECMO also could provide hypothermia management, we plan this study to evaluate the cerebroprotective effect of ECPR with induced hypothermia. We will try to analyze risk factors influencing patient survival and weaning from ECPR and the optimal management for this ominous prognosis group. Method: The patients were recruited into the ECPR group only if they: 1. in cardiac arrest that necessitated external or open-chest cardiac massage and a large amount of epinephrine (>5 mg) during CPR. 2. Could not be returned to spontaneous circulation within 10 to 20 min. After ECPR, the body temperature was started to be cooled down. Within 3 hours, the patients have been well studied to search for potential reason of CPR. If the patients have no heart problem or only intervention needed, they can be grouped into 1. Group 2 is the group, which some further operation must be delivered. Group 3 is the group who cannot afford to receive hypothermia (The physician in charge don't agree the trial.) In ECMO-supported patients, two resulting comparisons were of concern: 1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death. We attempted to identify the risk factors that affected weaning and survival, and we analyzed the effect of ECPR with hypothermia on survival. Expected result: We will prove ECPR with hypothermia is a perfect strategy. And within three groups of the patients, ECMO +induced hypothermia will be the most optimal choice.

NCT ID: NCT00934700 Completed - Clinical trials for Hypoxic Ischaemic Encephalopathy

Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia

TOBYXe
Start date: February 2012
Phase: N/A
Study type: Interventional

This is a randomised controlled trial in newborn infants with perinatal asphyxial encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve cerebral metabolism and structure.

NCT ID: NCT00930917 Completed - Clinical trials for Hypothermia, Preterm Infants

Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

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

It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss. We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap prevents postnatal heat loss.

NCT ID: NCT00915031 Completed - Prostate Cancer Clinical Trials

Use of Hypothermia During Robotic Prostatectomy

Start date: August 2009
Phase: N/A
Study type: Interventional

Robotic assisted laparoscopic radical prostatectomy (RLP) has gained widespread acceptance as a standard treatment for clinically localized prostate cancer. Despite the enhanced visualization and precise dissection afforded by the robotic platform, two major comorbidities affect a significant number of men: incontinence and erectile function. Urinary continence and erectile function It is commonly believed that the most important factor affecting continence is preservation of the external urinary sphincter complex which lies just below the prostate. Trauma to the urethral tissue itself after it is transected from the prostate and damage to the autonomic nerves that control this sphincter may lead to sphincteric dysfunction. In addition, dissection of the bladder may lead to bladder irritability which also plays a role in incontinence. Surgical removal of the prostate also causes significant inflammatory damage to the pelvic floor which likely delays recovery of urinary continence. The same trauma issues apply to sexual function. One possible method to protect the nerves and other tissues from operative trauma may be the use of local hypothermia (cold-ischemia) to the pelvis. Local tissue hypothermia using ice, ice slush, or cold irrigation has been safely and routinely used for decades in humans during brain, heart, and kidney surgery to minimize organ damage. Yet, this technique has never been applied to prostate surgery. We will accomplish local cooling of the pelvis using a cooling balloon inserted into the rectum. The cooling balloon is powered by an FDA approved cooling system developed by Innercool therapies. Temperatures of 57-86 degrees F (22+/-8 degrees C).

NCT ID: NCT00904228 Completed - Hypothermia Clinical Trials

Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room

Start date: September 2008
Phase: N/A
Study type: Interventional

The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º Celsius by the World Health Organization. The surface area of the head is about 20% of total body surface of a newborn infant and is a major source of heat loss. The objective is to compare rectal temperature upon admission to the neonatal intensive care between preterm neonates who had stockinet head covering and those who had plastic-lined stockinet head covering placed in the delivery room. The investigators aim to demonstrate that plastic-lined head covering is more effective than stockinet head covering alone in maintaining body temperature.

NCT ID: NCT00902057 Not yet recruiting - Clinical trials for Hypothermia Induced Impairment of Primary Haemostasis

Desmopressin for Bleeding Related to Low Body Temperature

Start date: June 2009
Phase: Phase 4
Study type: Interventional

To study, with a prospective randomised controlled design, whether the subcutaneous administration of the haemostatic drug desmopressin, may improve the impairment of primary haemostasis due to mildly decreased temperature.

NCT ID: NCT00901134 Completed - Cardiac Arrest Clinical Trials

Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

J-PULSE-HYPO
Start date: June 2008
Phase: N/A
Study type: Observational

Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of cardiac arrest are advancing, however, survival rate is still very low in the world. Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality after successful resuscitation which is urgent issue to be solved. Therapeutic hypothermia is part of a standardized treatment strategy for comatose survivors of cardiac arrest in the metabolic phase usually about 15 minutes after cardiac arrest. However, the evidences of the efficacy of therapeutic hypothermia are still few. The optimal candidates, temperature, the timing of initiation, the therapeutic windows and the rate for rewarming have not been defined clinically and should be established. The purpose of this research is the improvement in the outcomes for patients with coma after resuscitation from out-of-hospital cardiac arrest using therapeutic hypothermia established from the analysis of multicenter registry data.

NCT ID: NCT00890409 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy

Start date: May 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).

NCT ID: NCT00888641 Completed - Kidney Neoplasm Clinical Trials

A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Start date: June 2009
Phase: Phase 1
Study type: Interventional

Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In preparation for a definitive randomized controlled trial this pilot study will assess feasibility and variance data to be used for sample size estimation

NCT ID: NCT00886184 Completed - Cardiac Arrest Clinical Trials

Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest

HITUPPAC-BIO
Start date: February 2009
Phase: N/A
Study type: Interventional

The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.