Effects of Hypoxic-hyperoxic Preconditioning in Cardio-surgical Patients

NCT05354648 | Completed

• 1 other identifier: HHP-cardio
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Myocardial Reperfusion Injury; Hypoxia; Hyperoxia; Coronary Artery Disease

Keywords

myocardial protection; preconditioning; hypoxia; hyperoxia; ischemia-reperfusion injury; cardiopulmonary bypass; oxygen transport

Outcome Measures

Primary Outcomes (3)

• Number of Participants with complications

  Any type of complications in postoperative period

  60 days

• Mechanical ventilation

  Mechanical ventilation time

  60 days

• Rate of spontaneous sinus rhythm recovery

  Spontaneous sinus rhythm recovery after surgery

  14 days

Secondary Outcomes (11)

• Catecholamine support

  60 days

• Troponin T

  12 hours

• Endothelin-1

  1 day before surgery

• Endothelin-1 dynamics 1

  at the end of surgery

• Endothelin-1 dynamics 2

  24 hours after surgery

Study Arms (2)

Hypoxic-hyperoxic preconditioning (HHP)

ACTIVE COMPARATOR

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, and at the last stage, a period of breathing with atmospheric air until the cardio-pulmonary bypass is connected. The anaerobic threshold was determined 72 hours before surgery to establish a safe oxygen concentration in the respiratory gas mixture during the hypoxic phase of preconditioning.

Procedure: Hypoxic-hyperoxic preconditioning

Control

PLACEBO COMPARATOR

The anaerobic threshold was determined, however, patients in the control group were not preconditioned. Mechanical ventilation was carried out with individual settings maintaining the target values of PaO2 and PaCO2 (80 - 120 mm Hg and 35 - 45 mm Hg, respectively), until the cardio-pulmonary bypass was connected.

Procedure: Placebo

Interventions

Hypoxic-hyperoxic preconditioning PROCEDURE

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.

Also known as: HHP

Hypoxic-hyperoxic preconditioning (HHP)

Placebo PROCEDURE

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.

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the need for coronary artery bypass grafting (CABG)

You may not qualify if:

• age over 75 years
• emergency surgery
• diabetes mellitus
• exacerbation of a chronic disease 1 week before surgery
• any oncological disease at the time of the examination

Sponsors & Collaborators

• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia: lead
• Tomsk National Research Medical Center of the Russian Academy of Sciences: collaborator
• Siberian State Medical University: collaborator
• I.M. Sechenov First Moscow State Medical University: collaborator

Related Publications (1)

• Mandel IA, Podoksenov YK, Suhodolo IV, An DA, Mikheev SL, Podoksenov AY, Svirko YS, Gusakova AM, Shipulin VM, Yavorovskiy AG. Influence of Hypoxic and Hyperoxic Preconditioning on Endothelial Function in a Model of Myocardial Ischemia-Reperfusion Injury with Cardiopulmonary Bypass (Experimental Study). Int J Mol Sci. 2020 Jul 27;21(15):5336. doi: 10.3390/ijms21155336.

  PMID: 32727110 BACKGROUND

MeSH Terms

Conditions

Myocardial Reperfusion Injury; Hypoxia; Hyperoxia; Coronary Artery Disease; Reperfusion Injury

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Irina A Mandel, PhD

  Federal Research Clinical Center FMBA Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: June 1, 2015
• Primary Completion: January 15, 2016
• Study Completion: February 22, 2016
• Last Updated: May 9, 2022

Record last verified: 2022-04