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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05434455
• Other study ID #: 2022RIPC-delirium
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: December 31, 2023
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Delirium
• Postoperative Delirium

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days postoperatively or before discharge, whichever came first