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

• Sponsor: South Egypt Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04768751
• Collaborator: (none)
• Enrollment: 520
• Location: 1
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 29.1

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury; Ventricular Dysfunction; Myocardium; Injury	Diagnostic Test: kidney assessment

Study Design

• Study Type: Observational
• Actual Enrollment: 520 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Systolic Dysfunction After Non-Cardiac Surgery in Critical Patients
• Actual Study Start Date: Mar 5, 2019
• Actual Primary Completion Date: Aug 20, 2020
• Actual Study Completion Date: Aug 30, 2020

Outcome Measures

Primary Outcome Measures

1. development myocardial injury [through study completion, an average of 15 days]

   New echocardiographic findings suggestive of ischemia (new regional wall motion abnormalities) or cardiac troponin T >.0.32 ng/ml

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaa Ali Elzohry	Assuit		Egypt	+2071516

Sponsors and Collaborators

• South Egypt Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Ali M. Elzohry, 4- Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute, Assiut University, Egypt, South Egypt Cancer Institute
• ClinicalTrials.gov Identifier: NCT04768751
• Other Study ID Numbers: Acute Kidney injury
• First Posted: Feb 24, 2021
• Last Update Posted: Feb 24, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Kidney Injury; Ventricular Dysfunction; Wounds and Injuries

Study Results

No Results Posted as of Feb 24, 2021