- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05068167
Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery
September 24, 2021 updated by: Alaa Ali M. Elzohry, South Egypt Cancer Institute
Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery in Critical Patients
The incidence of acute kidney injury (AKI) postoperatively has been identified to be 21.6% in adults and 18.3% in hospitalized individuals.
Surgery-related AKI is a severe complication that is related not only to short-term complications as increases in mortality rate and development of cardiac complications but also with complications on long term, such as development of chronic kidney disease.
A better understanding of the mechanism of this hypthesis will lead to better management of this complication.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized blinded prospective study included 206patients who the candidate for major surgery at South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
From April 2018 till April 2019, a detailed history and careful examination, routine laboratory investigations were done, Baseline ECG was recorded 24hours before surgery and 48hours postoperative at ICU.
Study Type
Observational
Enrollment (Actual)
240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assuit, Egypt, +2071516
- Alaa Ali Elzohry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients who were candidates for major surgery in the Cancer Institute of South Egypt, Assiut University, Egypt.
Patients excluded from this study were patients with chronic cardiac diseases (myocardial ischemia, heart failure, Active severe infection, pregnancy, chronic kidney disease, DM, and advanced malignancy on chemotherapy or radiotherapy.
Description
Inclusion Criteria:
- patients who were candidates for major non cardiac surgery
Exclusion Criteria:
- chronic cardiac diseases (myocardial ischemia, heart failure), Active severe infection, pregnancy, chronic kidney disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Creatinine level
Time Frame: every 12 hours
|
Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours
|
every 12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
August 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
September 24, 2021
First Submitted That Met QC Criteria
September 24, 2021
First Posted (Actual)
October 5, 2021
Study Record Updates
Last Update Posted (Actual)
October 5, 2021
Last Update Submitted That Met QC Criteria
September 24, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACI after non cardiac surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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