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Aortic AneurysmNCT04569864

Mild vs Moderate Hypothermic Circulatory Arrest With Unilateral Anterograde Cerebral Perfusion in Hemiarch Replacement

A study testing Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion in people with Aortic Aneurysm, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of our study is to analyze the immediate and long-term results between patients undergoing hemiarch replacement with ACP under mild hypothermic (30-32 °C) circulatory arrest versus moderate hypothermic (26-28 °C) circulatory arrest. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Aortic Aneurysm
What is being tested?
Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteRussia
Study dates
6 Nov 2020to 20 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with ascending aortic aneurysm
  • Elective aortic hemiarch replacement
  • Able to provide written informed consent

Who cannot join

  • Surgery for acute aortic dissection or emergent operations
  • Patients with known/documented coagulopathy
  • Oncological disease (high degrees)
  • Severe chronic heart failure
  • Refusal of surgical treatment
  • Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
  • Severe carotid disease, defined as: any patient with previously documented carotid stenosis of > 70%, without neurological deficits; or carotid stenosis > 50% with neurological deficits; or previous carotid endarterectomy or stenting
  • Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • Tomsk NRMC

    Tomsk, 634012

Other trials in Russia

About this study

Official title: Comparing Mild Versus Moderate Hypothermic Circulatory Arrest With Unilateral Anterograde Cerebral Perfusion in Hemiarch Replacement

The aim of our study is to analyze the immediate and long-term results between patients undergoing hemiarch replacement with ACP under mild hypothermic (30-32 °C) circulatory arrest versus moderate hypothermic (26-28 °C) circulatory arrest. It is hypothesized that circulatory arrest using mild hypothermia (30-32°C) and uSACP will result in complications reduction, during aortic hemiarch replacement, when compared to moderate hypothermia (26-28°C) and uSACP. For this purpose all of the patient population will be randomized into 2 groups. The first group of the patients during aortic hemiarch replacement, mild hypothermia (30-32°C) will be used during circulatory arrest. The second group of the patients during aortic hemiarch replacement, moderate hypothermia (26-28°C) will be used during circulatory arrest.

Read the detailed description

Mild versus moderate hypothermic circulatory arrest during aortic hemiarch replacement Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion (SACP) is an important surgical technique, allowing complex aortic surgeries to be performed safely. One of the main positive aspects of the strategy for changing the hypothermia temperature is to reduce the systemic inflammatory response, minimize visceral organ dysfunction, and reduce the risk of postoperative bleeding - the adverse effects of hypothermia Patients will be operated for ascending aortic aneurysm in a hypothermic circulatory arrest with unilateral SACP. The main difference is during aortic hemiarch replacement, moderate hypothermia (26-28°C) and mild hypothermia (30-32°C) will be used during circulatory arrest. All data will be prospectively collected and recorded. All surgeries will be perform concurrently in the same time period. Experienced in aortic pathology surgeons will perform these operations.

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 30-32 °C or 26-28 °C, depending on to which treatment arm the patient has been randomized. 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.

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), urine output-up to 24-48 h, 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); inotropic support during 24-48 h (agent and dose (VIS)); length of stay (intensive care unit and total hospital days).

Before surgery and on 12-16 POD, patients will undergo neurocognitive screening by trained personnel. Neurocognitive tests will include: MOCA examinations, Schulte Table and The Bourdon Test.

In addition, indicators of specific markers of brain damage will be evaluated. Indicators such as neuron-specific enolase (NSE), glial fibrillary acidic protein (GFAP), brain-derived neurotrophic factor (BDNF) will be evaluated before surgery and on first POD. Also will be evaluated indicators of the hemostatic system: thrombin-antithrombin (TAT) complexes, prothrombin fragments 1+2, glu-plasminogen, tissue plasminogen activator (t-PA), endothelin 1-21 and thromboelastography (TEG) in following points - before surgery, lowest temperature during arrest time, after inactivation of heparin and 4 h after surgery.

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

Conditions
Aortic Aneurysm
Being tested
Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion
Medical subject headings
Aortic Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusionProcedure or surgery

    Hypothermic circulatory arrest provides protection to cerebral and visceral organs.

Study groups in NCT04569864
Study groupRoleWhat they receive
Mild hypothermia (30-32°C)ExperimentalDuring aortic hemiarch replacement, mild hypothermia (30-32°C) will be used during circulatory arrest.
Receives: Procedure: Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion
Moderate hypothermia (26-28°C)Active comparatorDuring aortic hemiarch replacement, moderate hypothermia (26-28°C) will be used during circulatory arrest.
Receives: Procedure: Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operative mortality

    Operative mortality (%) as assessed by data linkage to medical records Comparison of mild (30-32°C) vs moderate (26-28°C) hypothermia in aortic hemiarch surgery with respect to the incidence of death

    Measured: During the first 30 days after the procedure

  2. Composite of neurologic injury

    Percentage of patients with neurological complications is assessed. Single assessment by CT or MRI. More often if necessary. Comparison of mild (30-32°C) vs moderate (26-28°C) hypothermia in aortic hemiarch surgery with respect to incidence of neurologic injury, including transient ischemic attack (TIA), permanent neurological dysfunction (PND) or stroke and delirium

    Measured: During the first 30 days after the procedure

  3. Incidence of Acute Kidney Injury (AKI)

    The incidence of acute kidney injury (AKI) (%), defined as Stage 1 or greater using the KDIGO criteria. Using the KDIGO criteria, Stage 1 AKI is defined as an increase in serum creatinine of 1.5-1.9x the baseline or an increase >= 27umol/L with urine output <0.5 mL/kg/hour for 6-12 hours.

    Measured: During the first 30 days after the procedure

Secondary outcomes (6)
  1. Respiratory failure

    Percentage of patients with respiratory failure. Artificial ventilation for more than 48 hours requiring tracheostomy during ICU stay of the patient as assessed by data linkage to medical records

    Measured: During the first 30 days after the procedure

  2. Perioperative Myocardial Infarction

    Incidence of the myocardial infarction (%) is assessed by complex evaluation based on the ECG and echocardiographic changes as well as increase of the troponin level using serum assay

    Measured: 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. )

  3. Rates of re-exploration for bleeding

    Percentage of patients requiring re-exploration for bleeding. Comparison of mild (30-32°C) vs moderate (26-28°C) hypothermia in aortic hemiarch surgery with respect to the rates of mediastinal re-exploration (re-operation) for bleeding.

    Measured: During the first 3 days after the procedure

  4. Volume of perioperative blood transfusion

    Defined as the volume (mL) of all intraoperative and postoperative blood transfusions

    Measured: During the first 3 days after the procedure

  5. The duration of a patient's stay in the intensive care unit and on the hospital ward

    Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of a patient's stay in the intensive care unit and on the hospital ward.

    Measured: Up to 90 days after surgery

  6. Duration of cardiopulmonary bypass

    Differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery are assessed.

    Measured: During the index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start6 Nov 2020
  3. Primary completion1 Dec 2021
  4. Study completion20 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The total patient population will be randomized into 2 groups. The first group of the patients during aortic hemiarch replacement, mild hypothermia (30-32°C) will be used during circulatory arrest. (main group). The second group of the patients during aortic hemiarch replacement, moderate hypothermia (26-28°C) will be used during circulatory arrest. (control group).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04569864
Sponsor's protocol ID
Hypothermia
Status last verified
Apr 2023
First submitted
19 Sep 2020
Last updated
18 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion in people with Aortic Aneurysm, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operative mortality (time frame: During the first 30 days after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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