Hypothermia occurs when the body temperature drops below normal levels, affecting the body's ability to maintain essential functions. Clinical trials related to hypothermia often investigate treatment evaluations aimed at safely restoring body temper...

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Found 36 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are conducting a multicenter, randomized clinical trial to evaluate different surgical techniques for treating Acute Type A Aortic Dissection (ATAAD). The study aims to compare the safety and effectiveness of arch-clamping techniques performed under mild and moderate hypothermia against Sun's procedure using bilateral antegrade cerebral perfusion. The trial involves 306 adult participants diagnosed with ATAAD from multiple hospitals in China to better understand major adverse events and recovery outcomes after surgery. Participants undergo total arch replacement combined with frozen elephant trunk implantation, then are randomly assigned to one of three groups: arch-clamping under mild hypothermia, arch-clamping under moderate hypothermia, or Sun's procedure under moderate hypothermic circulatory arrest with bilateral antegrade cerebral perfusion. Each surgical method involves specific steps to restore blood flow and reconstruct arteries using grafts during the operation. During the study, participants are closely monitored for one year after surgery. Researchers assess major adverse events such as death, need for renal replacement therapy, stroke, and paraplegia. They also measure surgical factors including circulatory arrest time, cardiopulmonary bypass time, mechanical ventilation duration, and length of ICU stay. Follow-up evaluations help determine the safety and validity of the mild hypothermic arch-clamping technique compared to the others.

Age: 18Years - 70YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are studying very preterm infants born before 32 weeks gestational age who often experience hypothermia and anemia during their stay in the neonatal intensive care unit. This trial evaluates the use of a commercial blood warming device to prevent low body temperatures (below 36.56C) during packed red blood cell (PRBC) transfusions, which are commonly needed to treat anemia in these infants. The study aims to reduce hypothermia-related complications by improving transfusion practices. The trial compares two groups: one receives standard care with PRBC transfusions given without deliberate warming, and the other group receives transfusions warmed using the Ranger blood warmer device. The device uses aluminum heating plates to quickly and evenly warm blood to near body temperature, following blood bank guidelines. Transfusions last about 4 hours, and all details including timing are recorded by nurses. Participants will be closely monitored for body temperature during and after the transfusion, especially focusing on the occurrence of hypothermia within 12 hours and 1 hour after transfusion ends. Temperature data are collected for 24 hours after transfusion to ensure accuracy. The study measures how well the warming device maintains normal body temperature to improve care for very preterm infants at risk of hypothermia during blood transfusions.

Age: 24Weeks - 32WeeksAll GendersPhase Not Applicable
1 location
C

Actively Recruiting

Researchers are evaluating the effectiveness of two intravenous drugs, hydrocortisone and dexmedetomidine, in preventing and treating shivering after general anesthesia in patients undergoing abdominal surgeries. This is a randomized controlled clinical trial conducted at Ain Shams University hospitals, focused on adult patients aged 18 to 65 years who are undergoing abdominal open surgeries lasting up to 120 minutes. The study aims to compare these drugs' ability to reduce postoperative shivering and monitor hemodynamic changes. Participants are randomly assigned to one of two groups: Group A receives hydrocortisone at a dose of 2 mg/kg, and Group B receives dexmedetomidine at 1 microgram/kg. Both drugs are administered intravenously about 30 minutes before the anticipated end of surgery. Standard anesthesia protocols, including induction and maintenance, are followed, with monitoring of vital signs and core temperature throughout the procedure. After surgery, patients are extubated and transferred to the post-anesthesia care unit for observation. During the study, participants undergo regular monitoring of core temperature and vital signs at specific intervals. Shivering is assessed using a validated scale from 0 (no shivering) to 3 (severe whole-body shivering) during the 30 minutes after surgery while in the recovery area. The primary outcome is the number of patients who experience shivering in response to decreased body temperature. Secondary outcomes include observing any changes in heart rate and blood pressure. The total participation includes preoperative assessment, intraoperative treatment, and 30 minutes of postoperative monitoring.

Age: 18Years - 65YearsAll GendersPhase 4
1 location
C

Actively Recruiting

Researchers are exploring the safety, feasibility, and initial effectiveness of combining controlled cold exposure with standard PD-1/PD-L1 immunotherapy for adults with solid tumors. This phase I, single-center, open-label study plans to include 24 participants receiving standard immunotherapy either alone or in combination, according to routine clinical practice. The study aims to assess how cold exposure influences immune responses, tumor biomarkers, and patient outcomes alongside immunotherapy. Participants will undergo a 2-day cold acclimation before starting the combined treatment, with temperature-controlled exposure at approximately 20B0C on Day -2 and 18B0C on Day -1. From Day 1, participants will be exposed daily to 18B0C for 12 hours over 7 consecutive days while receiving their immunotherapy. If well tolerated, this cold exposure may be repeated during subsequent treatment cycles. Standard immunotherapy regimens are selected based on tumor type and clinical guidelines. During the study, researchers will monitor safety, tolerability, and adherence to the cold exposure protocol, recording adverse events from the start of the intervention until 30 days after treatment ends. They will also evaluate tumor response through imaging performed every 6-12 weeks for up to a year, and assess survival outcomes for up to 36 months. Additional assessments include immune profiling, metabolomics, gut microbiota analysis, patient-reported outcomes, and biomarker studies on tumor tissue when available. The total duration of participant involvement depends on treatment response and follow-up schedules.

Age: 18Years - 75YearsAll GendersPhase 1
1 location
C

Actively Recruiting

This research aims to monitor core body temperature in patients experiencing out of hospital cardiac arrest (OHCA) during transport and upon arrival at the hospital. The study observes how environmental temperature and measures to prevent hypothermia affect these patients. It follows guidelines from the European Resuscitation Council to ensure standard resuscitation methods are applied. During the study, an esophageal temperature probe is inserted at the scene while resuscitation is ongoing to measure core temperature. Environmental factors such as weather, altitude, patient activity, and hypothermia protection like clothing are also recorded. Temperature measurements continue during transport and upon the patient's arrival at the hospital. Participants will be monitored throughout resuscitation and transport, with data collected on body temperature, environmental conditions, and resuscitation details. Researchers will track the core temperature at hospital arrival and during return of spontaneous circulation (ROSC), as well as other factors like resuscitation time and use of mechanical chest compression devices. The study collects data over about one year, focusing on temperature and resuscitation outcomes.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Researchers are conducting a nationwide, registry-based observational study in Denmark to develop a Utstein-style drowning registry. The study aims to link data from the Danish Prehospital Drowning Data with inhospital electronic medical records to better understand drowning incidents since 2016. The purpose is to estimate 30-day mortality following drowning and explore factors associated with these outcomes, helping to guide future prevention and treatment strategies. The study collects and links fatal and non-fatal drowning data recorded by emergency medical services with hospital records. It groups patients into those who died within 30 days after the drowning incident and those who survived beyond this period. Neurological outcomes are assessed by trained observers using hospital records. The data also include hospital length of stay, ICU admissions, use and duration of mechanical ventilation, and survival to hospital discharge. Participants' information is gathered retrospectively through registries and medical records, with no direct intervention or treatment provided. Researchers measure outcomes such as mortality and neurological function 30 days post-drowning. Secondary measures include hospital and ICU stay details and mechanical ventilation needs. The study began in 2016 and continues to follow cases through to December 2025, aiming to inform targeted educational, rescue, and prevention efforts.

All Genders
1 location
D

Actively Recruiting

Researchers are studying the best dose of Dexmedetomidine to stop shivering in women undergoing scheduled elective cesarean deliveries. This trial focuses on patients who experience moderate to severe shivering during surgery and aims to find the dose that stops shivering in 90% of these patients within 5 minutes. The study uses a phase 4 design to evaluate this dosing in a real clinical setting. Participants who experience Grade 3 or 4 shivering during their cesarean delivery under spinal anesthesia will receive Dexmedetomidine intravenously. The dose for each patient will be determined using a sequential up-and-down method with a biased coin design, starting with an initial dose of 10 mcg. An anesthesia physician not involved in patient care prepares the drug to maintain objectivity. Spinal anesthesia is given with standard doses of bupivacaine, fentanyl, and morphine. During the study, shivering is graded using a five-point scale from no shivering to full body muscle activity. Researchers will monitor the effect of the drug on shivering within 5 minutes of administration while tracking maternal heart rate and dose amounts during surgery. The trial includes pre-operative screening, drug administration during the operation, and ongoing observation of responses. Participation ends after the intraoperative course, and safety is monitored throughout.

Age: 18Years +FEMALEPhase 4
1 location
E

Actively Recruiting

Healthy Volunteer

Researchers are investigating how caffeine affects the activity of brown adipose tissue (BAT) after exposure to mild cold. This study explores the role of adenosine A2A receptors in BAT activation, which is important for understanding potential treatments for metabolic diseases. The trial is a randomized, double-blind, placebo-controlled cross-over study involving healthy adults aged 18 to 40 years with moderate caffeine consumption. Participants will take a single oral dose of 200 mg caffeine or a placebo in two separate visits. After administration, they will undergo mild cold exposure using cooling sleeves around the waist that lower the skin temperature to 10°C or the lowest tolerable level without causing shivering. BAT activity will be measured using 18F-FDG PET/CT scans 30 minutes after injection of a radioactive tracer. Resting energy expenditure will also be assessed before and after treatment and cold exposure. During the study, participants will attend a screening visit and two main study visits in random order. Researchers will monitor energy expenditure, BAT activity, skin temperature, metabolite profiles, and other factors to evaluate the effects of caffeine versus placebo during cold exposure. The primary outcome is BAT uptake measured 30 minutes after intervention. The total participation period includes these visits and assessments, with safety and compliance closely followed.

Age: 18Years - 40YearsAll GendersPhase Not Applicable
1 location
E

Actively Recruiting

This research aims to investigate whether providing preemptive education by anesthesiologists can reduce the occurrence of maternal shivering during elective cesarean delivery. The study focuses on women undergoing this specific surgical procedure and seeks to answer if informing patients ahead of time about the anesthesia and surgery process affects intraoperative shivering. The trial is randomized and triple-blinded to ensure unbiased results and is sponsored by Seoul National University Hospital. Participants are divided into two groups: one group receives minimal information about the surgery with questions answered by the obstetrician, while the other group receives detailed preemptive education about the entire process—from anesthesia through recovery—provided by anesthesiologists in a 15-minute session. The study compares the effect of this education on maternal shivering during surgery. During the study, researchers will monitor participants from the moment they enter the operating room until they leave, which may last up to 180 minutes. They will measure the number of women experiencing shivering, body temperature, pain levels, and spinal anesthesia effects at various time points during and after surgery. Additional assessments include post-operative shivering, nausea, patient satisfaction, pain and analgesic use up to one day after surgery, and obstetric recovery quality. This thorough monitoring helps evaluate the full impact of preemptive education on the surgery experience and recovery.

Age: 19Years +FEMALEPhase Not Applicable
1 location
E

Actively Recruiting

Maintaining a newborn's body temperature during the first hour after birth is crucial for survival and adapting to life outside the womb. This trial evaluates how a thermoregulation bundle applied at birth affects newborns' body temperature, breathing rate, heart rate, oxygen levels, and breastfeeding outcomes. The study focuses on healthy, full-term babies and aims to support successful breastfeeding through improved thermal care. The thermoregulation bundle includes keeping the delivery room temperature between 23-26 degrees Celsius, immediate skin-to-skin contact, drying the baby starting from the head with a warm towel, placing a hat on the baby, covering the baby with a warm towel during skin-to-skin contact, and initiating breastfeeding within the first 30-60 minutes. One group of newborns receives this bundle, while the control group receives routine care following standard hospital protocols. Participants will be monitored closely during the first hour after birth for body temperature stability, heart rate, respiratory rate, oxygen saturation, and Apgar scores at 1 and 5 minutes. Researchers will also record the time to first breastfeeding and early breastfeeding success. The study begins shortly after birth and measures outcomes within 60 minutes postpartum, focusing on both physiological stability and breastfeeding initiation.

Age: 2Hours - 2HoursAll GendersPhase Not Applicable
1 location

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