Protein Kinase N1 Level in Patients Undergoing Cardiac Surgery

Protein Kinase N1 Level Predicts Acute Kidney Injury 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.

Study Overview

• Status: Completed
• Conditions: Surgery; Acute Kidney Injury; Extracorporeal Circulation; Complications
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Zhongnan Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the development of CSA-AKI	the development of CSA-AKI	1 Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI severity	AKI stage 1，stage 2，stage 3	1 Week
need for RRT	Reflect kidney function	1 Week
duration of AKI (≥7 days)	Reflect kidney function	1 Week
length of ICU stay	Reflect patient prognosis	up to 28 days
post-operative hospital stay	Reflect patient prognosis	up to 28 days

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Investigators: Study Director: ZhiYong Peng, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): March 14, 2021
• Study Completion (Actual): March 14, 2021

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 2017004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No