Clinical trial NCT04905225: The Gender Specific Effect on the Results of Ascending Aortic Replacement
Official title: The Gender Specific Effect on the Results of Ascending Aortic Replacement in Small Ascending Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ascending Aortic Aneurysm
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ascending aortic aneurysm with Hemiarch replacement

Brief summary: The aim of our study is to analyze the early and late results in men and women who underwent ascending aortic replacement in antegrade cerebral perfusion (ACP) with mild-to-moderate hypothermic circulatory arrest. Female gender is associated with poorer outcomes after surgical aorta replacement. Data on gender specific differences after ascending aortic replacement are conflicting.

Detailed description: Description of the procedures:

All surgical procedures will be performed via median sternotomy. During the aortic arch anastomosis, continuous, unilateral SACP using innominate artery will be employed. Unilateral SACP may be converted to bilateral ACP at the surgeon's discretion if adequate cerebral flows are not achieved or if there are concerns with cerebral oximetry measurements.

Once on CPB, the patient will be cooled to a nasopharyngeal (NP) temperature of either 26-32 °C. Rectal temperature with be monitored as an additional temperature sites. Unilateral SACP will only be initiated once the target temperature has been reached. SACP via the innominate artery will be commenced with target flows of 8-10 ml/kg/min and perfusion pressure of 60-80 mmHg. Perfusion adequacy will be evaluated using measurement of blood pressure in both radial arteries and cerebral oximetry using near-infrared spectroscopy (NIRS).

After completion of the aortic hemiarch replacement, CPB will be resumed and the patient re-warmed to 36 °C prior to coming off CPB, with a = 1 °C temperature difference between temperature monitoring sites (NP and rectal).

Intraoperative information will be collected from the anesthetic record, surgical notes and perfusion records. Intraoperative data collection will include total operative time, CPB time, cross-clamp time, hypothermic cardiac arrest time, uSACP time, lowest nasopharyngeal and rectal temperature, arterial pressure in both radial arteries, perfusion rate and perfusion pressure during both of CPB and unilateral SACP, lowest hemoglobin concentration (g/L) and hematocrit (%), acid-base indices, intraoperative red blood cell transfusion (units), highest dose/agent used for intraoperative inotrope or vasopressor support. Also during the surgery will be performed NIRS and BIS-monitoring(bispectral index).

Postoperative data will include valuation of following indicators: mortality (hospital mortality and death from any cause); neurological injury (TIA, stroke, delirium), MRI and CT-scan only in event of postoperative stroke; acute kidney injury (creatinine level prior and 1, 2, 4 postoperative day (POD), renal replacement therapy (dialysis); time of mechanical ventilation; re-exploration for bleeding, tamponade or other reasons; postoperative transfusion (packed red blood cells, platelets, fresh frozen platelets, cryoprecipitate); postoperative myocardial infarction (electrocardiogram and troponins); length of stay (intensive care unit and total hospital days).

Follow-up information will be collected using direct or phone contact with patients, relatives, or physicians.

Eligibility criteria: Inclusion Criteria:

* Patients with small ascending aortic aneurysm (5.0-5.5 cm)
* Elective procedure
* Able to provide written informed consent

Exclusion Criteria:

* Surgery for acute aortic dissection or emergent operations
* Refusal of surgical treatment
* Oncological disease (high degrees)
* Multiple organ failure

Primary outcomes:
measure: Operative mortality
timeFrame: During the first 30 days after the procedure
measure: All-cause mortality
timeFrame: Up to 5 years
Secondary outcomes:
measure: Perioperative Myocardial Infarction
timeFrame: During the first 30 days after the procedure (assessed by daily serum assay and ECG in the ICU and every 5 days after discharge from ICU. )
measure: Rates of re-exploration for bleeding
timeFrame: During the first 3 days after the procedure
measure: Respiratory failure
timeFrame: During the first 30 days after the procedure
measure: The duration of a patient's stay in the intensive care unit and on the hospital ward
timeFrame: Up to 90 days after surgery
measure: Incidence of Acute Kidney Injury (AKI)
timeFrame: During the first 30 days after the procedure
measure: Composite of neurologic injury
timeFrame: During the first 30 days after the procedure
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk NRMC
Study officials:
affiliation: TOMSK NRMC CARDIOLOGY RESEARCH INSTITUTE
name: Boris N Kozlov, Dr
role: STUDY_DIRECTOR
References: