Acute Kidney Injury as a Risk Factor for Myocardial Injur... | NCT04768751

Studies
Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Dysfunction

NCT04768751

Sponsor

South Egypt Cancer Institute

Status

Completed

Last Update Posted

Feb 24, 2021Actual

Enrollment

520Actual

Phase

Not provided

Conditions

Acute Kidney Injury
Ventricular Dysfunction
Myocardium; Injury

Interventions

kidney assessment

Countries

Egypt

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

Feb 2021

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

Mar 5, 2019Actual

Primary Completion Date

Aug 20, 2020Actual

Completion Date

Aug 30, 2020Actual

First Submitted Date

Feb 20, 2021

First Submission Date that Met QC Criteria

Feb 23, 2021

First Posted Date

Feb 24, 2021Actual

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

Feb 23, 2021

Last Update Posted Date

Feb 24, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alaa Ali M. Elzohry, 4- Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute, Assiut University, Egypt, South Egypt Cancer InstitutePrincipal Investigator

Lead Sponsor

South Egypt Cancer InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 classically described as an abrupt or rapidly reversible reduction in the excretion of nitrogenous waste products, including urea, nitrogen and creatinine. Acute kidney injury definition emphasizes on the filtration function of the kidney, a measure that is unique and easily and routinely measured .

Acute kidney injury is associated with significantly increased resource utilization and health care costs.

Major adverse cardiac events (MACE) after non cardiac surgery are a leading cause of morbidity and mortality. The reported incidence of postoperative myocardial infarction (POMI) among patients undergoing non cardiac surgery is between 3% and 6%.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

520Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
kidney assessment	Diagnostic Test	Urea, BUN, and Creatinine BLOOD LEVELS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
development myocardial injury	New echocardiographic findings suggestive of ischemia (new regional wall motion abnormalities) or cardiac troponin T >.0.32 ng/ml	through study completion, an average of 15 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with normal kidney functions and free normal heart functions, were enrolled to this study

Exclusion Criteria:

patients with chronic kidney disease, cardiac disease, who with minor operations, or emergency, were excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with normal kidney functions and free normal heart functions

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alaa Ali Elzohry		Asyut		+2071516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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
D018754	Ventricular Dysfunction
D014947	Wounds and Injuries

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided