Clinical trials: Targeted Temperature Management
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
Neonatal Encephalopathy
Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings
This pilot intervention trial will assess the feasibility of a live consultation between community hospital providers and tertiary care providers employing a novel teleconsult platform, Maine Neonatal Encephalopathy Teleconsult…
- Trial name
- NCT03706417
- Testing
- Telemedicine consult
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- MaineHealth
Narcotic Consumption, Pain
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures
This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice.
- Conditions
- Narcotic Consumption, Pain, Wound Healing, Patient Satisfaction
- Trial name
- NCT00950183
- Testing
- Iceman® Cold Therapy unit (djOrtho), Ice
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- OrthoCarolina Research Institute, Inc.
Cardiac Arrest
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial
Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully…
- Trial name
- THAPCA-OH (NCT00878644)
- Testing
- Therapeutic Hypothermia, Therapeutic Normothermia
- Where
- 34 sites in United States, Canada
- Volunteers
- 295 people
- Sponsor
- University of Michigan
Cardiac Arrest
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial
Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully…
- Trial name
- THAPCA-IH (NCT00880087)
- Testing
- Therapeutic Hypothermia, Therapeutic Normothermia
- Where
- 33 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- University of Michigan
Out-of-Hospital Cardiac Arrest
A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest
The objective of this study will be to assess the frequency of return of spontaneous circulation (ROSC), survival to admission, survival to discharge from the hospital, and neurologic function at time of discharge from the…
- Trial name
- NCT01413399
- Testing
- 4 degree chilled saline
- Where
- United States
- Volunteers
- 542 people
- Sponsor
- Wake Forest University Health Sciences
Postoperative Pain, Shoulder Pain
Compression and Cold Therapy on the Post-Operative Shoulder
The purpose of this study is to evaluate and compare clinical post-operative outcomes for patients using active cooling and compression device and those using ice bags and elastic wrap after acromioplasty or arthroscopic rotator…
- Trial name
- NCT00703729
- Testing
- Cold Compression (CC), Ice Wrap (IW)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- University of Colorado, Denver
Cardiogenic Shock
Cardiogenic Shock Intravascular Cooling Trial
The purpose of the study is to compare patients with cardiogenic shock who receive standard therapy plus therapeutic hypothermia (TH) to patients with cardiogenic shock who receive standard medical therapy alone in order to…
- Trial name
- CHILL-SHOCK (NCT03141255)
- Testing
- IVTM™ System, Quattro® Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Chicago
Atrial Fibrillation
Esophageal Cooling for AF Ablation
The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation…
- Trial name
- eCoolAF (NCT03691571)
- Testing
- Esophageal Cooling, Control
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- University of Pennsylvania
Neonatal Encephalopathy
CoolCap Followup Study-Coordination of Participating Centers
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial.
- Trial name
- NCT00581581
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Rochester
Encephalopathy, Hypoxic-Ischemic
Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
This research is being done to find out the safety of the investigational study drug, Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE).
- Trial name
- HIE (NCT01862250)
- Testing
- Clonidine (Duraclon®)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Johns Hopkins 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
Traumatic Brain Injury
Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device
The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with…
- Trial name
- NCT02420639
- Testing
- Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.
- Where
- Ukraine
- Volunteers
- 12 people
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Cardiac Arrest
Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock
Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong inflammatory response, result in multiple organ failure, even death.
- Trial name
- NCT02633358
- Testing
- Therapeutic hypothermia group
- Where
- Taiwan
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- China Medical University Hospital
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-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
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
Hypoxic Ischemic Encephalopathy
California Transport Cooling Trial
Hypoxic ischemic encephalopathy (HIE) remains a major cause of death and severe disability despite advances in neonatal and perinatal medicine. Therapeutic hypothermia is the single most promising intervention for HIE.
- Trial name
- CTCT (NCT01683383)
- Testing
- Device (servo-regulated cooling), Control (standard practice)
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Stanford University
Infant, Newborn, Asphyxia Neonatorum
Optimising Newborn Nutrition During Therapeutic Hypothermia.
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia.
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition
- Trial name
- NCT03278847
- Testing
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia, Received parenteral nutrition during therapeutic hypothermia
- Where
- 2 sites in United Kingdom
- Volunteers
- 6,030 people
- Sponsor
- Imperial College London
Hypoxic Ischemic Encephalopathy
Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Selective head cooling or whole body hypothermia has become the standard of care for neonatal hypoxia-ischemia encephalopathy (HIE).
- Trial name
- DANCE (NCT01471015)
- Testing
- Darbepoetin alfa
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Utah