The Effect of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery Between Diabetic and Non-Diabetic Patients

NCT ID: NCT06841757

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-07-31

Brief Summary

This randomized controlled study aims to evaluate the effects of Remote Ischemic Preconditioning (RIPC) on diastolic function in patients undergoing coronary artery bypass grafting (CABG). The study will compare diabetic and non-diabetic patients to determine whether RIPC improves myocardial relaxation and reduces diastolic dysfunction, as assessed by the E/e' ratio at multiple time points during the surgery.

Conditions

Coronary Artery Disease; Diabetes Mellitus; Diastolic Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diabetic with Remote ischemic preconditioning

Remote Ischemic Preconditioning (RIPC) Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation.

Group Type: EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type: BEHAVIORAL

Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation

Non diabetic with Remote ischemic preconditioning

Remote Ischemic Preconditioning (RIPC) Non-diabetic patients who undergo Remote ischemic preconditioning using the same ischemia/reperfusion protocol as the diabetic group.

Group Type: EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type: BEHAVIORAL

Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation

Diabetic without Remote ischemic preconditioning

Diabetic patients who receive standard care for CABG surgery without Remote ischemic preconditioning

Group Type: NO_INTERVENTION

No interventions assigned to this group

Non diabetic without Remote ischemic preconditioning

Non-diabetic patients who receive standard care for CABG surgery without RIPC.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Remote ischemic preconditioning

Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All adult patients scheduled for elective isolated on-pump CABG surgery for two- to three-vessel coronary artery disease.
• Both males and females will be included.
• In the diabetic groups: Type II diabetes currently requiring and adhering to insulin therapy for at least the past 3 months
• During cardiopulmonary bypass, the temperature will range from 28-33°C using an esophageal temperature probe.
• Antegrade warm cardioplegia will be given by the cardiovascular perfusionist.
• Baseline diastolic function will be obtained preoperatively using transthoracic echocardiography done within the six months prior to the surgery

Exclusion Criteria

• Combined CABG and valve surgery, emergency CABG.
• Type I diabetes, Type 2 diabetes managed with oral hypoglycemic agents without insulin in the past 3 months
• Peripheral vascular disease (PVD) affecting the upper limbs.
• Acute coronary syndrome (ACS); acute or recent myocardial infarction.
• Left ventricular ejection fraction ≤30%.
• Serious pulmonary disease necessitating oxygen supplementation or mechanical ventilation.
• Renal failure, defined as eGFR < 30 mL/min/1.73 m² or requiring renal replacement therapy (dialysis).
• Liver failure, including Child-Pugh Class B or C cirrhosis, severe hepatocellular dysfunction, or listed for liver transplantation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alzahraa Khalil Marie

OTHER

Sponsor Role: lead

Responsible Party

Alzahraa Khalil Marie

Assistant lecturer in Cairo university

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ahmed Alagaty Ehsan Alagaty, Professor of anesthesia

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo university hospital

Cairo, , Egypt

Countries

Egypt

References

Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

Reference Type: BACKGROUND

PMID: 33309175 (View on PubMed)

Other Identifiers

MD-342-2024

Identifier Type: -

Identifier Source: org_study_id