Acute Kidney InjuryNCT05390281
Preoperative Level of Hemoglobin A1c and Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery
An observational study of Acute Kidney Injury, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- increase in serum creatinine
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ASA physical status II-III
- scheduled to undergo isolated coronary artery bypass grafting
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Acute Kidney Injury
- Being tested
- increase in serum creatinine
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increase in serum creatinineDiagnostic test
any of the following: increase in serum creatinine by ≥ 0.3 mg/dl within 48 h of surgery or increase in serum creatinin
| Study group | Role | What they receive |
|---|---|---|
| Pre-diabetic group | Patients with preoperative HbA1c 5.7-6.4% (group A) (prediabetics) Receives: 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) Receives: Diagnostic Test: increase in serum creatinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (1)
Patients in need of RRT
The number of patients requiring postoperative renal replacement therapy
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jun 2019
- Primary completion1 Jul 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M.Samir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390281
- Sponsor's protocol ID
- FMASU MD 368/2018
- Status last verified
- Jan 2025
- First submitted
- 14 May 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Level of Hemoglobin A1c and the Incidence of Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery: a Cohort Study
- ClinicalTrials.gov ID
- NCT05390281
- Acronym / sponsor ID
- FMASU MD 368/2018
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-diabetic group | – | Diagnostic Test: increase in serum creatininePatients with preoperative HbA1c 5.7-6.4% (group A) (prediabetics) |
| Diabetic group | – | Diagnostic Test: increase in serum creatininePatients 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) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ASA physical status II-III
- scheduled to undergo isolated coronary artery bypass grafting
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| increase in serum creatinineany of the following: increase in serum creatinine by ≥ 0.3 mg/dl within 48 h of surgery or increase in serum creatinin | Diagnostic test | Diabetic group, Pre-diabetic group |
Primary outcome
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
1 secondary outcome
Patients in need of RRT
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatinine level (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.