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Effects of Hypoxic-hyperoxic Preconditioning in Cardio-surgical Patients

NCT05354648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-05-09

No results posted yet for this study

Summary

Coronary artery bypass grafting (CABG) with cardiopulmonary bypass is a common surgical therapy for patients suffering from coronary artery diseases. The heart is subjected to a long period of ischemia due to the occlusion of the aorta. The heavy burden of myocardial ischemia-reperfusion injury (IRI) thus induces cardiomyocyte death, which can paradoxically reduce the beneficial effect of CABG. Preconditioning by moderate hypoxia or hyperoxia serves as an effective drug-free method to increase the organism's resistance to negative effects, including IRI.

Conditions

Interventions

PROCEDURE

Hypoxic-hyperoxic preconditioning

Patients were intubated and mechanically ventilated with the target values of PaO2 and PaCO2 (80 - 120 mm Hg and 35 - 45 mm Hg, respectively) under the inhalation anesthesia. HHP was carried out as follows: breathing with a hypoxic gas mixture for 10 min with the development of hypoxemia, then breathing with a hyperoxic gas mixture for 30 minutes, then a period of breathing with atmospheric air (normoxia and normocapnia) until the cardio-pulmonary bypass is connected.

PROCEDURE

Placebo

Patients were intubated and mechanically ventilated with the target values of PaO2 and PaCO2 (80 - 120 mm Hg and 35 - 45 mm Hg, respectively) under the inhalation anesthesia until the cardio-pulmonary bypass is connected.

Sponsors & Collaborators

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

    collaborator OTHER

  • Siberian State Medical University

    collaborator OTHER

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

    lead OTHER_GOV

Principal Investigators

  • Irina A Mandel, PhD · Federal Research Clinical Center FMBA Russia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2016-01-15
Completion
2016-02-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05354648 on ClinicalTrials.gov