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NCT Number: NCT06707350

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

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.

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Key information

Conditions

Cardiopulmonary Bypass Cardiovascular Diseases Inflammation Inflammatory Response During Cardiac Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

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

Treatment and study plan

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

sham condition (control group)

Device

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

Primary outcomes

  1. ∆SOFA

    Time frame: within the prior 7 days after cardiac surgery.

    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.

Secondary outcomes

  1. Plasma interleukin-1 levels

    Time frame: within the prior 7 days after cardiac surgery.

    Plasma interleukin-1 levels within the prior 7 days after cardiac surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Liu, MD

CONTACT

[email protected]

18801281613

Yong-feng Shao, MD

CONTACT

[email protected]

02568303101

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Official study title

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

Acronym: PANDA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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