Protein Kinase N1 Level in Patients Undergoing Cardiac Su... | NCT05386940

Studies
Protein Kinase N1 Level in Patients Undergoing Cardiac Surgery

NCT05386940

Sponsor

Zhongnan Hospital

Status

Completed

Last Update Posted

May 23, 2022Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Acute Kidney Injury
Extracorporeal Circulation; Complications
Surgery

Interventions

PKN1 level

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2019Actual

Primary Completion Date

Mar 14, 2021Actual

Completion Date

Mar 14, 2021Actual

First Submitted Date

May 15, 2022

First Submission Date that Met QC Criteria

May 19, 2022

First Posted Date

May 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2022

Last Update Posted Date

May 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PKN1 Tertile 1			Other: PKN1 level
PKN1 Tertile 2			Other: PKN1 level
PKN1 Tertile 3			Other: PKN1 level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PKN1 level	Other	different PKN1 level after on-pump cardiac surgery	PKN1 Tertile 1 PKN1 Tertile 2 PKN1 Tertile 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
AKI severity	AKI stage 1，stage 2，stage 3	1 Week
need for RRT	Reflect kidney function	1 Week

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ZhiYong Peng	Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongnan Hospital of Wuhan University		Wuhan	Hubei	430000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

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