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Completed

NCT Number: NCT05386940

Protein Kinase N1 Level in Patients Undergoing Cardiac Surgery

Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Identification of relevant biomarkers may lead to early diagnosis and improve patient outcomes and health care costs. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Protein kinase N1 (PKN1) is associated with ischemia-reperfusion injury. In this study, relationship between PKN1 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of PKN1 for early prediction of CSA-AKI was further evaluated.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

About this study

Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42% and is the second leading cause of AKI (after sepsis) in the intensive care unit (ICU). CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Early detection of CSA-AKI could improve patient outcomes and health care costs through targeted interventions. Thus, identification of relevant biomarkers may lead to early diagnosis. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Protein kinase N1 (PKN1) is associated with ischemia-reperfusion injury. Nowadays, little is known about relationship between PKN1 and CSA-AKI. In this study, relationship between PKN1 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of PKN1 for early prediction of CSA-AKI was further evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients (≥18 years old) underwent on-pump cardiac surgery
  • admitted to ICU immediately after surgery

Exclusion criteria

  • Patients younger than 18 years
  • with prior AKI
  • end-stage kidney disease
  • need for chronic hemodialysis
  • pregnant patients
  • unable to give written consent for participation

Treatment and study plan

PKN1 level

Other

different PKN1 level after on-pump cardiac surgery

Primary outcomes

  1. the development of CSA-AKI

    Time frame: 1 Week

    the development of CSA-AKI

Secondary outcomes

  1. AKI severity

    Time frame: 1 Week

    AKI stage 1,stage 2,stage 3

  2. need for RRT

    Time frame: 1 Week

    Reflect kidney function

  3. duration of AKI (≥7 days)

    Time frame: 1 Week

    Reflect kidney function

  4. length of ICU stay

    Time frame: up to 28 days

    Reflect patient prognosis

  5. post-operative hospital stay

    Time frame: up to 28 days

    Reflect patient prognosis

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Official study title

Protein Kinase N1 Level Predicts Acute Kidney Injury in Patients Undergoing Cardiac Surgery

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 23, 2022
Registry last updated
May 23, 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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