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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05434455

Collaborator

(none)

216

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Delirium Cardiac Surgery	Device: RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Effects of Remote Ischemic Preconditioning(RIPC) on the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery: A Pilot Randomized Clinical Trial

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 14, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
No Intervention: Con The control group had a deflated cuff placed on the upper arm for the same time.

Arm

Intervention/Treatment

Experimental: 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.

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

No Intervention: Con

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

Outcome Measures

Primary Outcome Measures

Incidence of postoperative delirium [7 days postoperatively or before discharge, whichever came first]
Patients were assessed for postoperative delirium by the Confusion Assessment Method (CAM) from the time they were transferred to the ICU at the end of surgery until 7 days postoperatively or before discharge, whichever came first

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT05434455

Other Study ID Numbers:

2022RIPC-delirium

First Posted:

Jun 28, 2022

Last Update Posted:

Jun 30, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Study Results

No Results Posted as of Jun 30, 2022