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Protein Kinase N1 Level in Patients Undergoing Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT05386940
Recruitment Status : Completed
First Posted : May 23, 2022
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Zhongnan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Kidney Injury Extracorporeal Circulation; Complications Surgery Other: PKN1 level

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Protein Kinase N1 Level Predicts Acute Kidney Injury in Patients Undergoing Cardiac Surgery
Actual Study Start Date : July 22, 2019
Actual Primary Completion Date : March 14, 2021
Actual Study Completion Date : March 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
PKN1 Tertile 1 Other: PKN1 level
different PKN1 level after on-pump cardiac surgery

PKN1 Tertile 2 Other: PKN1 level
different PKN1 level after on-pump cardiac surgery

PKN1 Tertile 3 Other: PKN1 level
different PKN1 level after on-pump cardiac surgery




Primary Outcome Measures :
  1. the development of CSA-AKI [ Time Frame: 1 Week ]
    the development of CSA-AKI


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients (≥18 years old) underwent on-pump cardiac surgery and admitted to ICU immediately after surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05386940


Locations
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China, Hubei
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Sponsors and Collaborators
Zhongnan Hospital
Investigators
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Study Director: ZhiYong Peng Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University
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Responsible Party: Zhongnan Hospital
ClinicalTrials.gov Identifier: NCT05386940    
Other Study ID Numbers: 2017004
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases