Preoperative Level of Hemoglobin A1c and Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery

NCT05390281 | Completed

• 1 other identifier: FMASU MD 368/2018
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patients in need of RRT

  7 days

Other Outcomes (1)

• Length of ICU stay

  7days

Study Arms (2)

Pre-diabetic group

Patients with preoperative HbA1c 5.7-6.4% (group A) (prediabetics)

Diagnostic Test: increase in serum creatinine

Diabetic group

Patients with preoperative HbA1c \> or = 6.5% till 7% or \> 7% in case of emergency surgery or rapidly progressive cases with no time for long-term glycemic control (group B) (diabetics)

Diagnostic Test: increase in serum creatinine

Interventions

increase in serum creatinine DIAGNOSTIC_TEST

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

Diabetic group; Pre-diabetic group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study compared the AKI incidence between patients with prediabetic level of HbA1c (5.7-6.4) and patients with elevated levels of HbA1c (\> or = 6.5). Forty patients who underwent elective CABG were enrolled in this cohort study.

You may qualify if:

• ASA physical status II-III
• scheduled to undergo isolated coronary artery bypass grafting

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: May 25, 2022
• Study Start: June 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)