Protein Kinase N1 Level in Patients Undergoing Cardiac Surgery

NCT05386940 | Completed

• 1 other identifier: 2017004
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Extracorporeal Circulation; Complications; Surgery

Outcome Measures

Primary Outcomes (1)

• the development of CSA-AKI

  the development of CSA-AKI

  1 Week

Secondary Outcomes (5)

• AKI severity

  1 Week

• need for RRT

  1 Week

• duration of AKI (≥7 days)

  1 Week

• length of ICU stay

  up to 28 days

• post-operative hospital stay

  up to 28 days

Study Arms (3)

PKN1 Tertile 1

Other: PKN1 level

PKN1 Tertile 2

Other: PKN1 level

PKN1 Tertile 3

Other: PKN1 level

Interventions

PKN1 level OTHER

different PKN1 level after on-pump cardiac surgery

PKN1 Tertile 1; PKN1 Tertile 2; PKN1 Tertile 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• ZhiYong Peng

  Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 23, 2022
• Study Start: July 22, 2019
• Primary Completion: March 14, 2021
• Study Completion: March 14, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)