Identifying biomarkers to predict kidney injury in diabetic patients
Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing Coronary Revascularisation
This study is testing if certain markers in blood and urine can help predict kidney injury in diabetic patients who are at risk during procedures using contrast dye.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT00948116 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with diabetes mellitus who are at risk of acute kidney injury during procedures involving contrast dye, such as percutaneous coronary interventions. The study aims to develop a biomarker panel that can predict the likelihood of contrast-induced nephropathy, which is a significant complication for these patients. By collecting serum and urine samples from participants, researchers will identify natural biomarkers that could enhance early detection and improve patient outcomes. The study will not involve any additional interventions beyond routine clinical care.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with diabetes and an eGFR of less than 60 ml/min who are scheduled for a PCI procedure.
Not a fit: Patients with cardiogenic shock, those on renal replacement therapy, or individuals unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer diagnostic and treatment procedures for diabetic patients at risk of kidney injury.
How similar studies have performed: Other studies have explored biomarkers for kidney injury in diabetic patients, but this specific approach to developing a biomarker panel is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 18 years, known diabetes mellitus or BM on arrival consistent with probable diagnosis of diabetes, eGFR \<60 ml/min 2. Undergoing a PCI procedure 3. Agrees to the additional collection of blood and urine samples as outlined above 4. Agrees to access of their clinical records for the collection of relevant medical data 5. No history or signs of drug abuse 6. Able to understand and sign the written Informed Consent Form 7. Able and willing to follow the Protocol requirements Exclusion Criteria: 1. Cardiogenic shock 2. Pregnancy 3. Patient on renal replacement therapy (haemodialysis/CAPD/renal transplant) 4. Known clinically significant infection such as HIV, Hepatitis or TB 5. Any patient determined not able to make a reasoned, informed consent prior to the planned interventional procedure
Where this trial is running
London
- The London Chest Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Akhil Kapur — Consultant Cardiologist and Honorary Senior Lecturer, Barts and the London Nhs Trust
- Study coordinator: Akhil Kapur
- Email: akhil.kapur@bartsandthelondon.nhs.uk
- Phone: 0208 983 2413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.