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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05390281
Other study ID # FMASU MD 368/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date October 1, 2020

Study information

Verified date May 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: The development of acute kidney injury (AKI) is an important indicator of clinical outcomes after cardiac surgery. Elevated preoperative hemoglobin A1c level may be associated with acute kidney injury in patients undergoing coronary artery bypass grafting. This study will investigate the association of preoperative HbA1c levels with AKI after isolated coronary artery bypass grafting (CABG).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 45 Years to 70 Years
Eligibility Inclusion Criteria: - ASA physical status II-III - scheduled to undergo isolated coronary artery bypass grafting Exclusion Criteria: - Patients with history of renal failure - Patients with history of hepatic failure - Patients with history of heart failure - previous cardiac surgery - cerebrovascular event in the last 30 days - percutaneous coronary intervention in the last 30 days prior to operation - peripheral arterial disease - malignancy - infectious diseases - patients who required surgical revision - patients who required postoperative intra-aortic balloon pump - patients with CBP time > 120 min or aortic cross clamp time > 90 min

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
increase in serum creatinine
any of the following: increase in serum creatinine by = 0.3 mg/dl within 48 h of surgery or increase in serum creatinin

Locations

Country Name City State
Egypt Ain-Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Length of ICU stay The duration of postoperative patient stay in the intensive care 7days
Primary serum creatinine level increase in serum creatinine by = 0.3 mg/dl within 48 h of surgery or increase in serum creatinine to = 1.5 times baseline within 3 days of cardiac surgery 3 days
Secondary Patients in need of RRT The number of patients requiring postoperative renal replacement therapy 7 days
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