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Clinical Trials/NCT05434455
NCT05434455
Unknown
Not Applicable

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

Shanghai Zhongshan Hospital0 sites216 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
Shanghai Zhongshan Hospital
Enrollment
216
Primary Endpoint
Incidence of postoperative delirium
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients undergoing elective cardiac surgery;
  • age ≥ 18 yr;
  • 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.

Outcomes

Primary Outcomes

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

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