NCT04433468

Brief Summary

To observe the effect of RIPC on the function of vital organs after cardiac surgery, and to explore its possible mechanism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 11, 2020

Last Update Submit

June 28, 2022

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

  • The incidence of acute renal injury after operation

    According to the (KDIGO) guidelines for improving the prognosis of renal disease

    within 7 days after operation

  • The incidence of postoperative delirium

    CAM score greater than 22

    within 7 days after operation

Study Arms (2)

RIPC

ACTIVE COMPARATOR
Device: RIPC

Control

NO INTERVENTION

Interventions

RIPCDEVICE

The tourniquet attached to the upper limb was inflated and blocked for 5 minutes, then deflated for 5 minutes to restore blood flow and induce ischemic preconditioning.

RIPC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with aortic valve, mitral valve, tricuspid valve, ascending aortic disease and coronary atherosclerosis who were admitted to hospital for elective valve repair, replacement, artificial vascular replacement or coronary artery bypass grafting.
  • age 18-80 years old.
  • No restriction on gender.
  • ASA grade II\~III.
  • NYHAII\~III level.
  • the patient or his family member has signed the informed consent form for the clinical trial

You may not qualify if:

  • those who are disabled in the selected test.
  • less than 5 years of education.
  • The preoperative left ventricular ejection fraction ((LVEF)) was less than 40%.
  • Myocardial infarction occurred in nearly one month.
  • malignant tumor, hematological disease, severe liver and kidney dysfunction, recent severe infection, etc.
  • History of nervous system, immune system and mental illness.
  • recent operation history of heart, brain, lung, liver, kidney and other important organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

September 1, 2020

Primary Completion

January 31, 2021

Study Completion

March 31, 2021

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)