Protein Kinase N1 Level in Patients Undergoing Cardiac Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05386940
• Other study ID #: 2017004
• Status: Completed
• Start date: July 22, 2019
• Est. completion date: March 14, 2021

Study information

• Verified date: January 2022
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 14, 2021
• Est. primary completion date: March 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Extracorporeal Circulation; Complications
• Surgery

Intervention

Other:
• PKN1 level
different PKN1 level after on-pump cardiac surgery

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the development of CSA-AKI	the development of CSA-AKI	1 Week
Secondary	AKI severity	AKI stage 1,stage 2,stage 3	1 Week
Secondary	need for RRT	Reflect kidney function	1 Week
Secondary	duration of AKI (=7 days)	Reflect kidney function	1 Week
Secondary	length of ICU stay	Reflect patient prognosis	up to 28 days
Secondary	post-operative hospital stay	Reflect patient prognosis	up to 28 days