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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05068167
Other study ID # ACI after non cardiac surgery
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date September 30, 2020

Study information

Verified date September 2021
Source South Egypt Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date September 30, 2020
Est. primary completion date August 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Kidney function test
Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours

Locations

Country Name City State
Egypt Alaa Ali Elzohry Assuit

Sponsors (1)

Lead Sponsor Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Creatinine level Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours every 12 hours
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