Status:
COMPLETED
The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiopulmonary Bypass.
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Valvular Heart Disease
Aortic Arch Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to evaluate the effects of intermittent hypoxic-hyperoxic training (IHHT) to protect myocardium against perioperative myocardial injury during cardiac surgery using cardiopul...
Detailed Description
This is a prospective, single-center, randomized controlled clinical trial, which will involve patients over 18 years old who would be recruited consecutively during pre-admission consultation at the ...
Eligibility Criteria
Inclusion
- 1\. Written consent to participate in the study 2. Male or female patients over 18 years 3. Indications for planned replacement of the aortic or mitral valves or operations on the aortic arch.
Exclusion
- 1\. Individual intolerance to the intermittent hypoxic-hyperoxic training
- 2\. Acute coronary syndrome after hospitalization and before the surgery
- 3\. The presence of an acute infectious process after hospitalization and before the surgery (fever, leukocytosis with a shift leukocyte formula to the left, increased erythrocyte sedimentation rate (ESR), increased C-reactive protein)
- 4\. Uncompensated hypertension at the time of the procedure (systolic blood pres-sure more than 160 mm Hg, diastolic blood pressure more than 110 mm Hg)
- 5\. Loss of consciousness, severe dizziness
- Non-inclusion criteria:
- Occlusive atherosclerotic disease of lower limbs,
- Acute coronary syndrome within 4 weeks before entry
- Preoperative renal insufficiency (serum creatinine higher than 200 mmol/L),
- Acute infectious diseases
- Partial and secondary generalized forms of epilepsy,
- Uncompensated hypertension (Blood pressure at the time of the procedure: systolic blood pressure more than 160 mm Hg, diastolic blood pressure more than 110 mm Hg)
- Severe bronchial asthma with the development of respiratory failure of the II-III degree and individual intolerance to oxygen deficiency.
- 9\. Severe hepatic impairment (class C child-Pugh) Intervention type
- 10\. Mental illness (if patients are not capable of understanding the nature, significance and implications of the clinical trial)
- 11\. Myocardial insufficiency as a component of multiple organ failure in decompensation of liver and kidney diseases
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04833283
Start Date
January 25 2021
End Date
December 1 2022
Last Update
December 7 2022
Active Locations (1)
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1
University Clinical Hospital №1
Moscow, Russia, 119991