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

May 22, 2022 updated by: Ghada M.Samir, Ain Shams University

Association Between Preoperative Level of Hemoglobin A1c and the Incidence of Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery: a Cohort Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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

  • Egypt
      • Cairo, Egypt
        • Ain-Shams University

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

45 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-diabetic group
Patients with preoperative HbA1c 5.7-6.4% (group A) (prediabetics)
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
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
any of the following: increase in serum creatinine by ≥ 0.3 mg/dl within 48 h of surgery or increase in serum creatinin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine level
Time Frame: 3 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients in need of RRT
Time Frame: 7 days
The number of patients requiring postoperative renal replacement therapy
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: 7days
The duration of postoperative patient stay in the intensive care
7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

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)

June 1, 2019

Primary Completion (ACTUAL)

July 1, 2020

Study Completion (ACTUAL)

October 1, 2020

Study Registration Dates

First Submitted

May 14, 2022

First Submitted That Met QC Criteria

May 22, 2022

First Posted (ACTUAL)

May 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 368/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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