Clinical trials: Hypothermia, Induced
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
Underdosing of Other General Anesthetics
Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex
The primary efficacy endpoint is the time from the start of administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild…
- Trial name
- NCT01965067
- Testing
- sugammadex
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- MSD Korea Ltd.
Anesthesia Induced Hypothermia, Inadvertent Perioperative Hypothermia
Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia
The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active Self-Warming Blanket Used for Continuous Active Warming to…
- Trial name
- NCT01900067
- Testing
- BARRIER® EasyWarm Active Self-Warming Blanket
- Volunteers
- 271 people
- Sponsor
- Molnlycke Health Care AB
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
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
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
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
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
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
Hypothermia
A Comparison of Inhalation vs. Intravenous Induction
To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane
- Trial name
- INHvsIV (NCT02331108)
- Testing
- Selection of anesthetic induction technique
- Where
- United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Albert Einstein Healthcare Network
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
Fever, Ischemic Stroke
Impact of Fever Prevention in Brain Injured Patients
This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients.
- Conditions
- Fever, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- Trial name
- INTREPID (NCT02996266)
- Testing
- Targeted Temperature Management, Standard Care
- Where
- 40 sites in United States, Australia and 4 more
- Volunteers
- 686 people
- Sponsor
- C. R. Bard
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.
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
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
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
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
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
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