Clinical trials: Targeted Temperature Management
Out-Of-Hospital Cardiac Arrest
Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest
To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3 different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.
- Trial name
- FROST (NCT02035839)
- Testing
- Target Temperature Management of 34°C, Target Temperature Management of 32°C, Target Temperature Management of 33°C
- Where
- 14 sites in Germany, Spain
- Volunteers
- 150 people
- Sponsor
- ZOLL Circulation, Inc., USA
Encephalopathy, Hypoxic Ischemic
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic…
- Trial name
- NCT05767476
- Testing
- Clinical and instrumental neurological assessment
- Where
- 2 sites in Italy
- Volunteers
- 70 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Stroke, Ischemic
Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke
Therapeutic hypothermia (TH) in stroke has demonstrated robust neuroprotection in animals especially after ischemia-reperfusion injury, but its safety and efficacy remain controversial.
- Trial name
- THIS (NCT05779176)
- Testing
- Therapeutic hypothermia
- Where
- China
- Volunteers
- 252 people
- Sponsor
- RenJi Hospital
Hypoxic Ischemic Encephalopathy
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
- Trial name
- NCT01765218
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Kristin R Hoffman
Cardiac Arrest
Pre-Hospital Cooling in Cardiac Arrest Patients
Type of study: Pilot prospective nonrandomized feasibility clinical study. Aim of the study: To assess the feasibility of pre-hospital therapeutic mild hypothermia in patients successfully resuscitated from out-of-hospital…
- Trial name
- PRE-COOL (NCT00915421)
- Testing
- Induction of therapeutic mild hypothermia
- Where
- 2 sites in Czechia
- Volunteers
- 40 people
- Sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech Republic
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
Cardiac Arrest
A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest
Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients resuscitated after ventricular fibrillation arrest.
- Trial name
- NCT00676598
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Advocate Hospital System
Organ Donor, Brain Death
Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function
Each year, only one third of patients registered on the waiting list receive a kidney transplant. Numerous paths are being explored with the aim of reversing this shortage.
- Conditions
- Organ Donor, Brain Death, Kidney Transplant; Complications, Critical Illness
- Trial name
- HYPOREME (NCT03098706)
- Testing
- Procedure control: normothermia, Procedure active
- Where
- 54 sites in France
- Volunteers
- 532 people
- Sponsor
- Nantes University Hospital
Intracerebral Hemorrhage, Targeted Temperature Management
Targeted Temperature Management Via Bladder Monitoring in ICH
The goal of this clinical trial is to learn whether a bladder temperature monitoring-guided targeted temperature management (TTM) strategy improves functional recovery in patients with severe intracerebral hemorrhage, compared to…
- Trial name
- BTTM-ICH (NCT07302009)
- Testing
- Bladder Temperature Monitoring, Standard Temperature Monitoring Group
- Where
- China
- Volunteers
- 318 people
- Sponsor
- Yanyan Gong
Neonatal Encephalopathy, Feeding; Difficult, Newborn
OMT to Improve Feeding After Hypothermia
The goal of this study is to determine if infants with neonatal encephalopathy will achieve full oral feeds faster after therapeutic hypothermia has completed if they are treated with osteopathic manipulative treatment.
- Trial name
- NCT03380013
- Testing
- Osteopathic Manipulative Treatment (OMT)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- MaineHealth
Respiratory Distress Syndrome, Adult
Trial of Therapeutic Hypothermia in Patients With ARDS
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of ~40%, and has no known treatment other than optimization of support.
- Trial name
- CHILL (NCT04545424)
- Testing
- Hypothermia, Neuromuscular Blocking Agents, Standard of care
- Where
- 19 sites in United States
- Volunteers
- 340 people
- Sponsor
- University of Maryland, Baltimore
Cardiac Arrest
Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients
This trial is currently a single-center, randomized, double-blind investigator initiated prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI).
- Trial name
- CAPITALCHILL (NCT02011568)
- Testing
- Therapeutic Hypothermia
- Where
- Canada
- Volunteers
- 389 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Acute Ischemic Stroke
COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
This study will develop and validate a novel, active/conductive combined head and neck cooling system to selectively cool the ischemic penumbra during the acute phase of stroke, reducing neuronal damage and improving stroke…
- Trial name
- PEN-Cool (NCT07844096)
- Testing
- PEN-Cool Conductive Head-and-Neck Cooling System, Standard Reperfusion Therapy / Routine Care
- Where
- 5 sites in India
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Christian Medical College and Hospital, Ludhiana, India
Cardiac Arrest With Successful Resuscitation, Hypothermia
Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest
Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers are in use, together with analgesia and sedation, during the cooling process in many centers to prevent shivering.
- Conditions
- Cardiac Arrest With Successful Resuscitation, Hypothermia, Skeletal Muscle Relaxant Overdose
- Trial name
- RELAX (NCT01719770)
- Testing
- rocuronium
- Where
- Austria
- Volunteers
- 60 people
- Sponsor
- Medical University of Vienna
Pain, Acute, Alloimmunisation in Pregnancy
Efficacy of Manuel Pressure and Local Cold Spray in Reducing Injection Pain in Pregnant Women
A randomized controlled study was planned to determine the effect of manual pressure and local cold spray application on the intensity of pain, fear, hemodynamic parameters, and satisfaction related to the pain reduction of human…
- Conditions
- Pain, Acute, Alloimmunisation in Pregnancy, Injection Site, Injection Fear
- Trial name
- NCT06231719
- Testing
- Cold Spray, Manuel Pressure, Standard Injection Procedure
- Where
- Turkey (Türkiye)
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Gulsum Coskun
Hypoxic-Ischemic Encephalopathy, Post-Cardiorespiratory Arrest Coma
Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest
- Conditions
- Hypoxic-Ischemic Encephalopathy, Post-Cardiorespiratory Arrest Coma, Cardiac Arrest
- Trial name
- NCT03024021
- Testing
- Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Tepecik Training and Research Hospital
Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury
Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia
This prospective, single-center observational cohort study evaluated whether continuous cerebral and bilateral renal near-infrared spectroscopy (NIRS) monitoring during therapeutic hypothermia distinguishes term neonates with…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonatal, Asphyxia Neonatorum
- Trial name
- NCT07743099
- Testing
- 1- Continuous Cerebral Near-Infrared Spectroscopy, 2- Continuous Bilateral Renal Near-Infrared Spectroscopy
- Where
- Turkey (Türkiye)
- Volunteers
- 46 people
- Sponsor
- Agah Bahadır Öztürk,MD
Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy
PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia.
- Conditions
- Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Caffeine
- Trial name
- NCT05295784
- Testing
- Caffeine citrate
- Where
- 2 sites in United States
- Sponsor
- University of Arkansas
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment.
- Trial name
- NCT03837717
- Testing
- Holding, Saliva collection, No Holding
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- MaineHealth
Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability.
- Conditions
- Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia
- Trial name
- NEATO (NCT01913340)
- Testing
- Erythropoietin, Normal saline
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco