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

NCT ID: NCT06707350

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiopulmonary Bypass Cardiovascular Diseases Inflammatory Response During Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RIPC Group

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

Group Type EXPERIMENTAL

Remote ischemic preconditioning (RIPC)

Intervention Type DEVICE

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

Control group

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

Group Type SHAM_COMPARATOR

sham condition (control group)

Intervention Type DEVICE

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

Interventions

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Remote ischemic preconditioning (RIPC)

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

Intervention Type DEVICE

sham condition (control group)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hong Liu

Principal Investigator of China 5A Network

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong-feng Shao, MD

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Hong Liu, MD

Role: CONTACT

[email protected]
18801281613

Yong-feng Shao, MD

Role: CONTACT

[email protected]
02568303101

Facility Contacts

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Hong Liu, MD

Role: primary

[email protected]
18801281613

Yong-feng Shao, MD

Role: backup

[email protected]
02568303101

Hong Liu, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 39319450 (View on PubMed)

Other Identifiers

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PANDA VII

Identifier Type: -

Identifier Source: org_study_id