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OpenTrials
Completed

NCT Number: NCT04433468

Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.

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

Completed

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Key information

Conditions

Cardiac Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

180 Fenglin Road

Shanghai, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

RIPC

Device

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.

Primary outcomes

  1. The incidence of acute renal injury after operation

    Time frame: within 7 days after operation

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

  2. The incidence of postoperative delirium

    Time frame: within 7 days after operation

    CAM score greater than 22

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2020
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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