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

NCT04569864 | Completed

• 1 other identifier: Hypothermia
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (3)

• 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

  During the first 30 days after the procedure

• 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

  During the first 30 days after the procedure

• 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.

  During the first 30 days after the procedure

Secondary Outcomes (6)

• Respiratory failure

  During the first 30 days after the procedure

• Perioperative Myocardial Infarction

  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. )

• Rates of re-exploration for bleeding

  During the first 3 days after the procedure

• Volume of perioperative blood transfusion

  During the first 3 days after the procedure

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

  Up to 90 days after surgery

Study Arms (2)

Mild hypothermia (30-32°C)

EXPERIMENTAL

During aortic hemiarch replacement, mild hypothermia (30-32°C) will be used during circulatory arrest.

Procedure: Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion

Moderate hypothermia (26-28°C)

ACTIVE COMPARATOR

During aortic hemiarch replacement, moderate hypothermia (26-28°C) will be used during circulatory arrest.

Procedure: Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion

Interventions

Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion PROCEDURE

Hypothermic circulatory arrest provides protection to cerebral and visceral organs.

Mild hypothermia (30-32°C); Moderate hypothermia (26-28°C)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tomsk NRMC

Tomsk, 634012, Russia

Location

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Dmitry S Panfilov, PhD

  Tomsk National Research Medical Center of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Investigator and Coordinator

Model Details: 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).

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: September 30, 2020
• Study Start: November 6, 2020
• Primary Completion: December 1, 2021
• Study Completion: November 20, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

RU (1)