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Effect of RIPC on the Prevention of POD in Patients Undergoing Cardiac Surgery

NCT ID: NCT05434455

Last Updated: 2022-06-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

Brief Summary

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Postoperative delirium (POD) is one of the most frequent neurological complications in elderly patients and is closely associated with longer ICU stay and hospitalization, deterioration of long-term neurocognitive function, and increased mortality. The incidence of POD is significantly higher in elderly patients undergoing cardiac surgery than in other populations. Therefore, the prevention of POD is an important clinical problem to be solved urgently. In this study, we intend to observe the effect of RIPC on the prevention and treatment of POD in patients undergoing cardiac surgery through a prospective randomized controlled trial.

Detailed Description

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Conditions

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Postoperative Delirium Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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RIPC

RIPC was induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion on the upper arm. By using blood pressure cuff inflation, patients in the RIPC group were exposed to a pressure 50 mmHg higher than the systolic radial artery pressure baseline.

Group Type EXPERIMENTAL

RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion

Intervention Type DEVICE

RIPC was induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion on the upper arm. By using blood pressure cuff inflation, patients in the RIPC group were exposed to a pressure 50 mmHg higher than the systolic radial artery pressure baseline.

Con

The control group had a deflated cuff placed on the upper arm for the same time.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion

RIPC was induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion on the upper arm. By using blood pressure cuff inflation, patients in the RIPC group were exposed to a pressure 50 mmHg higher than the systolic radial artery pressure baseline.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing elective cardiac surgery;
* age ≥ 18 yr;
* any sex;
* American Society of Anesthesiologists (ASA) class ≥II class;
* New York Heart Association (NYHA) ≥II class.

Exclusion Criteria

* emergency surgery;
* a history of cardiovascular surgery;
* peripheral vascular disease affecting the upper limbs;
* acute myocardial infarction (MI) up to 14 days before surgery;
* a history of severe injuries and operations within 3 months before cardiac surgery;
* a history of cancer and chronic autoimmune diseases.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2022RIPC-delirium

Identifier Type: -

Identifier Source: org_study_id