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

June 29, 2022 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

216

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative delirium
Time Frame: 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
7 days postoperatively or before discharge, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2022

Primary Completion (ANTICIPATED)

July 14, 2022

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (ACTUAL)

June 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022RIPC-delirium

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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