Protective Effect of RIPC Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)

NCT06707350 | Not Yet Recruiting DMC

• 1 other identifier: PANDA VII
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Remote ischaemic pre-conditioning (RIPC) has been recognized as a low-cost, non-invasive intervention method by applying brief ischaemia and reperfusion on an arm or a leg. Previous studies have mainly focused on the organoprotective effects of RIPC in patients undergoing cardiac surgery. However, whether it has an organ-protecting effect is still highly debated. We aimed to determine whether intensive RIPC can prevent from negative inflammatory response and organ dysfunction as well as postoperative complications in patients undergoing cardiovascular surgery.

Conditions

Cardiopulmonary Bypass; Cardiovascular Diseases; Inflammatory Response During Cardiac Surgery

Keywords

inflammation

Outcome Measures

Primary Outcomes (1)

• ∆SOFA

  the change in sequential organ failure assessment score \[∆SOFA\]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score.

  within the prior 7 days after cardiac surgery.

Secondary Outcomes (1)

• Plasma interleukin-1 levels

  within the prior 7 days after cardiac surgery.

Study Arms (2)

RIPC Group

EXPERIMENTAL

6 cycles of 5-minute inflation and 5-minute deflation on 2 upper and lower libms with a blood pressure cuff at 72, 36, 24 hours before surgery

Device: Remote ischemic preconditioning (RIPC)

Control group

SHAM COMPARATOR

8 cycles of 5-minute inflation to a pressure of 20 mm Hg followed by 5-minute cuff deflation on 2 upper and lower libms with a blood pressure cuff at 72, 36, 24 hours before surgery

Device: sham condition (control group)

Interventions

Remote ischemic preconditioning (RIPC) DEVICE

8 cycles of 5-minute inflation and 5-minute deflation on 2 upper and lower limbs with a blood pressure cuff

RIPC Group

sham condition (control group) DEVICE

8 cycles of 5-minute inflation to a pressure of 20 mm Hg followed by 5-minute cuff deflation.

Control group

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 at high risk for organ dysfunctions who underwent elective cardiovascular surgery requiring cardiopulmonary bypass (CPB);
• age of 18 -80 years old, regardless of gender;
• subjects voluntarily participate in the trialand sign the informed consent;

You may not qualify if:

• \) Arm fracture, skin injury or infection;
• \) There is limb nerve injury;
• \) Limb placement PICC, arteriovenous fistula and other devices that affect armband placement;
• \) There are basic vascular lesions and poor blood supply at the extremities;
• \) Limb thrombosis.

Sponsors & Collaborators

• Nanjing Medical University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

• Jia P, Ji Q, Zou Z, Zeng Q, Ren T, Chen W, Yan Z, Shen D, Li Y, Peng F, Su Y, Xu J, Shen B, Luo Z, Wang C, Ding X. Effect of Delayed Remote Ischemic Preconditioning on Acute Kidney Injury and Outcomes in Patients Undergoing Cardiac Surgery: A Randomized Clinical Trial. Circulation. 2024 Oct 22;150(17):1366-1376. doi: 10.1161/CIRCULATIONAHA.124.071408. Epub 2024 Sep 25.

  PMID: 39319450 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yong-feng Shao, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Hong Liu, MD

CONTACT

18801281613; dr.hongliu@foxmail.com

Yong-feng Shao, MD

CONTACT

02568303101; yfshaojph@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of China 5A Network

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

CN (1)