Circulatory Arrest, Hypothermia, Type A Aortic Dissection
Conditions
Brief summary
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.
Interventions
PROCEDURERetrograde Inferior Vena Caval Perfusion
Retrograde Inferior Vena Caval Perfusion is achieved by tethering the inferior vena cava with a band around the cannula and by clamping the distal end of the inferior vena cava drainage tube, which allowed a pump to drive oxygenated blood into the inferior vena cava. Pump pressure is maintained at 20-30 mmHg, and blood flow is maintained at 8-12 mL/min/kg. The aim of RIVP is to maintain the lower body perfusion during circulation arrest, and reduce the ischemia-associated vital organ injury.
PROCEDURESelect antegrade cerebral perfusion
Antegrade cerebral perfusion is achieved using a 12 F cannula inserted into the brachiocephalic artery or right axillary artery. The antegrade perfusion flow rate is maintained at 6-12 mL/min/kg
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite major complications | up to 12 months | Newly Postoperative Renal Failure;Surgical Re-exploration；Operative Mortality;Deep Sternal Wound Infection;Stroke/Cerebrovascular Accident;Paraplegia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transient Neurological Deficit | up to 30 days | 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. |
| Acute Kidney Injury not requiring Dialysis | up to 30 days | Kidney Disease Improving Global Outcomes (KDIGO) guidelines17 |
| Respiratory Failure | up to 30 days | — |
| Postoperative Prolonged Intubation | up to 30 days | 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 |
| Paraparesis | up to 30 days | 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) |
| Myocardial Infarction | up to 30 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 12 months | Any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain |
| The number of volume of blood products transfusion | up to 30 days | The number of units of packed red blood cells , fresh-frozen plasma, pooled platelets and cryoprecipitate administered was collected from blood bank records |
| Myocardial infarction | 12 months | 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） |
| Length of ICU stay | up to 30 days | The duration of staying ICU postoperatively, time between administrated in ICU after the procedure to discharge from the ICU |
| Length of postoperative stay | up to 30 days | 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 |
| Gastrointestinal bleed | up to 30 days | 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. |
| Postoperative ascites | up to 30 days | 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. |
| Death | 12 months | since incident surgery |
| New onset dialysis (since incident surgery) status | 12 months | Renal failure requiring dialysis |
Countries
China
Contacts
Primary ContactLei Du, M.D
Backup ContactJing Lin, M.D
Outcome results
None listed