Hypothermia Clinical Trial
— CARTAROfficial title:
The Effect of Combination of Selective Antegrade Cerebral Perfusion With Retrograde Inferior Vena Caval Perfusion on the Outcomes in Patients Underwent Total Aortic Arch Replacement
This study is designed as a multicenter, randomized, assessor- blinded clinical trial.The primary aim of this trial is to assess whether retrograde inferior venal caval perfusion combined selective antegrade cerebral perfusion(ACP)under mild hypothermia, compared with moderate hypothermia combined with selective ACP alone, improves the outcome for the patients undergoing total aortic arch replacement.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Patient aged 18 yr-65yr 2. Patient underwent total aortic arch replacement Exclusion Criteria: 1. Inability to understand/give informed consent, 2. Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial. 3. Inability to obtain superior and inferior vena caval cannulation due to pericardium adhesion |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital of Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The number of volume of blood products transfusion | The number of units of packed red blood cells , fresh-frozen plasma, pooled platelets and cryoprecipitate administered was collected from blood bank records | up to 30 days | |
Other | Length of ICU stay | The duration of staying ICU postoperatively, time between administrated in ICU after the procedure to discharge from the ICU | up to 30 days | |
Other | Length of postoperative stay | the number of days between procedure and discharge, including any time patients spent at hospitals or long-term acute care facilities after transfer from our institution | up to 30 days | |
Other | Gastrointestinal bleed | Gastrointestinal bleed is defined as unambiguous clinical or endoscopic evidence of blood in the gastrointestinal tract. Upper gastrointestinal bleeding (or haemorrhage) is that originating proximal to the ligament of Treitz, in practice from the oesophagus, stomach and duodenum. Lower gastrointestinal bleeding is that originating from the small bowel or colon. | up to 30 days | |
Other | Postoperative ascites | Accumulation or retention of free fluid in the abdominal peritoneal cavity between the tissues lining the abdomen and abdominal organs. The fluid may be serous, hemorrhagic, or the result of inflammation or tumor metastasis to the peritoneum. | up to 30 days | |
Other | Death | since incident surgery | 12 months | |
Other | New onset dialysis (since incident surgery) status | Renal failure requiring dialysis | 12 months | |
Other | Stroke | Any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain | 12 months | |
Other | Myocardial infarction | Increase in serum cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and at least one of the following criteria: symptoms of ischaemia; new or presumed new significant ST segment or T wave ECG changes or new left bundle branch block; development of pathological Q waves on ECG; radiological or echocardiographic evidence of new loss of viable myocardium or new regional wall motion abnormality; identification of an intracoronary thrombus at angiography or autopsy(since incident surgery) | 12 months | |
Primary | Composite major complications | Newly Postoperative Renal Failure;Surgical Re-exploration;Operative Mortality;Deep Sternal Wound Infection;Stroke/Cerebrovascular Accident;Paraplegia | up to 12 months | |
Secondary | Respiratory Failure | up to 30 days | ||
Secondary | Transient Neurological Deficit | The occurrence of postoperative agitation, confusion, delirium, obtundation or a transient focal neurologic deficit (resolution within 72 hours) without any evidence of new structural abnormality on computed tomography or magnetic resonance imaging. | up to 30 days | |
Secondary | Acute Kidney Injury not requiring Dialysis | Kidney Disease Improving Global Outcomes (KDIGO) guidelines17 | up to 30 days | |
Secondary | Myocardial Infarction | up to 30 days | ||
Secondary | Postoperative Prolonged Intubation | patients aged 18 years and older who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours Patients who require intubation for more than 24 hours | up to 30 days | |
Secondary | Paraparesis | Motor weakness in any lower extremity muscle group or unilateral paraplegia (Tarlov score 1-4 or, if present, a score of zero in a single lower extremity) | up to 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Not yet recruiting |
NCT05306392 -
Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation
|
N/A | |
Completed |
NCT02685176 -
Head and Torso Rewarming Using a Human Model for Severe Hypothermia
|
N/A | |
Completed |
NCT02586974 -
Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response
|
N/A | |
Withdrawn |
NCT02812069 -
WarmSmart Warming Protocol
|
N/A | |
Completed |
NCT02121574 -
Accuracy of Zero-flux and Ingestible Thermometers
|
N/A | |
Not yet recruiting |
NCT02211703 -
National Epidemiologic Survey on the Incidence of Perioperative Hypothermia
|
N/A | |
Completed |
NCT02742818 -
Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
|
N/A | |
Completed |
NCT02177903 -
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
|
N/A | |
Recruiting |
NCT01866384 -
Targeted Temperature Management After Intracerebral Hemorrhage
|
Phase 2 | |
Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
Completed |
NCT01722955 -
Pre-warmed Intravenous Fluids and Monitored Anesthesia Care
|
N/A | |
Completed |
NCT01793337 -
Core Body Temperature Measurement During Hot and Cold Environmental Exposure
|
N/A | |
Completed |
NCT01559675 -
Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery
|
N/A | |
Terminated |
NCT01018576 -
Delayed Cord Clamping in Premature Infants
|
N/A | |
Completed |
NCT00904228 -
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
|
N/A | |
Terminated |
NCT00822796 -
Thermogard™ Efficacy Trial
|
N/A | |
Completed |
NCT00334360 -
Dexmed/Buspirone Synergism on Shivering
|
Phase 4 | |
Not yet recruiting |
NCT06283771 -
The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering
|
N/A | |
Completed |
NCT04399902 -
Study to Actively Warm Trauma Patients
|
N/A |