Clinical trials: Hypothermia
Hypoxic-Ischemic Encephalopathy
Holding, Stress, and Bonding During Therapeutic Hypothermia
Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period.
- Trial name
- NCT03079284
- Testing
- Holding during cooling
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Alexa Craig
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Cardiac Arrest
Microcirculatory Perfusion in Patients With Coma After Out-of-hospital Cardiac Arrest
The hypothesis is: In patients after an out of hospital cardiac arrest, treated with therapeutic hypothermia (33°C) will be found significantly more microcirculatory abnormalities, compared to the same group of patients treated…
- Trial name
- NCT01850485
- Testing
- microcirculation by SDF and NIRS, in 33 and 36 degrees
- Where
- Netherlands
- Volunteers
- 22 people
- Sponsor
- Frisius Medisch Centrum
Hypoxic Ischaemic Encephalopathy
Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
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.
- Trial name
- TOBYXe (NCT00934700)
- Testing
- Xenon gas
- Where
- United Kingdom
- Volunteers
- 92 people
- Sponsor
- Imperial College London
Heart Arrest, Cardiac Arrest
Impact of Speed Of Rewarming After CaRdiac Arrest and ThErapeutic Hypothermia
Comparing the production of interleukin 6 (inflammatory cytokine) in two heating speed (slow rewarming rate: 0.25 ° C / h or fast rewarming rate 0.50 ° C / h) at the completion of a period of targeted temperature at 33°C after…
- Conditions
- Heart Arrest, Cardiac Arrest, Hypothermia
- Trial name
- ISOCRATE (NCT02555254)
- Testing
- Low Speed of Rewarming, High Speed of Rewarming
- Where
- France
- Volunteers
- 58 people
- Sponsor
- Centre Hospitalier Departemental Vendee
Out-of-hospital Cardiac Arrest
Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest
The overall goal of this study is to determine whether initiating hypothermia in cardiac arrest patients as soon as possible in the field results in a greater proportion of patients who survive to hospital discharge compared to…
- Trial name
- NCT00391469
- Testing
- Rapid infusion of 2 liters of 4oC normal saline, Rapid infusion of cold normal saline
- Where
- United States
- Volunteers
- 1,359 people
- Sponsor
- University of Washington
Stroke, Acute
The Intravascular Cooling in the Treatment of Stroke 2/3 Trial
The purpose of this trial is to determine whether the combination of thrombolysis and hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.
- Trial name
- ICTuS2/3 (NCT01123161)
- Testing
- hypothermia and anti-shivering treatment, Group1: IV t-PA and normothermia
- Where
- 31 sites in United States, Austria and 1 more
- Volunteers
- 120 people
- Sponsor
- University of California, San Diego
Traumatic Brain Injury
Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
The investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.
- Trial name
- NCT01333488
- Testing
- Arctic Sun, Magnesium Sulfate
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- United States Department of Defense
Hypoxic-Ischemic Encephalopathy, Pain
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Management of neonatal pain and sedation often includes opioid therapy. A growing body of evidence suggests long-term harm associated with neonatal opioid exposure.
- Trial name
- DICE (NCT04772222)
- Testing
- Dexmedetomidine Hydrochloride, Morphine Sulfate
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Utah
Prostate Cancer
Use of Hypothermia During Robotic Prostatectomy
Robotic assisted laparoscopic radical prostatectomy (RLP) has gained widespread acceptance as a standard treatment for clinically localized prostate cancer.
- Trial name
- NCT00915031
- Testing
- UroCool
- Where
- United States
- Volunteers
- 738 people
- Sponsor
- University of California, Irvine
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
Acute Myocardial Infarction
COOL AMI EU Pivotal Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)
The objective of this trial is to evaluate the safety and effectiveness of therapeutic hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction…
- Trial name
- NCT03173313
- Testing
- Intravascular permissive hypothermia as an adjunct to PCI
- Where
- Slovenia
- Volunteers
- 111 people
- Sponsor
- ZOLL Circulation, Inc., USA
Stroke, Acute
Reperfusion With Cooling in Cerebral Acute Ischemia
The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic…
- Trial name
- ReCCLAIM (NCT01585597)
- Testing
- Zoll- Coolgaurd 3000
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Emory University
Hypothermia
Study of a New Clinical Device for Reducing Body Core Temperature
This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study of a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at University Medical Center Brackenridge (UMCB)…
- Trial name
- NCT01996982
- Testing
- CCS Device
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Seton Healthcare Family
Infant, Newborn, Hypoxia, Brain
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01192776
- Testing
- Whole-body Cooling
- Where
- 19 sites in United States
- Volunteers
- 364 people
- Sponsor
- NICHD Neonatal Research Network
Orthostatic Hypotension, Hemodynamic Instability
Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery
The purpose of this study is to evaluate the effect of low dose versus high dose steroids vital signs of patients currently on steroids or recently treated with steroids undergoing major colorectal surgery.
- Conditions
- Orthostatic Hypotension, Hemodynamic Instability, Fever, Hypothermia
- Trial name
- NCT01559675
- Testing
- Hydrocortisone High Dose, Hydrocortisone Low Dose
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Cedars-Sinai Medical Center
Hypothermia, Anesthesia
Electric Warming Mattress to Prevent IPH During LSCS
This study will demonstrate whether an electric warming mattress can reduce the number of patients who get cold and shiver after elective cesarean section.
- Conditions
- Hypothermia, Anesthesia, Obstetric Anesthesia Problems
- Trial name
- ObsIPH (NCT01054209)
- Testing
- Warming with warming mattress
- Where
- United Kingdom
- Volunteers
- 116 people
- Sponsor
- Brighton and Sussex University Hospitals NHS Trust
Hypothermia Neonatal
Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care (KMC) is a safe and effective method of warming; however, it is not always feasible, and not possible in settings such as resuscitation or…
- Trial name
- NCT03031431
- Testing
- Non-Electric Infant Warmer
- Where
- Rwanda
- Volunteers
- 130 people
- Sponsor
- Boston Children's Hospital
Hypoxic Ischemic Encephalopathy
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
- Trial name
- NCT00620711
- Testing
- Olympic Cool Cap
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Vanderbilt University
Hypothermia
Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response
The aim of this study is to assess if the conditioning of the insufflation carbon dioxide (CO2) allows for an additional benefit in terms of prevention of the heat loss, when compared with the usual prevention with a forced warm…
- Trial name
- NCT02586974
- Testing
- Humigard
- Where
- Italy
- Volunteers
- 64 people
- Sponsor
- A.O.U. Città della Salute e della Scienza