Back to resultsEffect of RIPC on the Prevention of POD in Patients Undergoing Cardiac Surgery
Primary Purpose
Postoperative Delirium, Cardiac Surgery
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Delirium
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
RIPC
Con
Arm Description
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.
The control group had a deflated cuff placed on the upper arm for the same time.
Outcomes
Primary Outcome Measures
Incidence of postoperative delirium
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05434455
First Posted
June 22, 2022
Last Updated
June 29, 2022
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05434455
Brief Title
Effect of RIPC on the Prevention of POD in Patients Undergoing Cardiac Surgery
Official Title
Effects of Remote Ischemic Preconditioning(RIPC) on the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery: A Pilot Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 14, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium, Cardiac Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RIPC
Arm Type
Experimental
Arm Description
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.
Arm Title
Con
Arm Type
No Intervention
Arm Description
The control group had a deflated cuff placed on the upper arm for the same time.
Intervention Type
Device
Intervention Name(s)
RIPC induced with 3 cycles of 5 minutes of ischaemia and 5 minutes of reperfusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of postoperative delirium
Description
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
Time Frame
7 days postoperatively or before discharge, whichever came first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of RIPC on the Prevention of POD in Patients Undergoing Cardiac Surgery
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