Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes

NCT ID: NCT00948116

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-24
• Study Completion Date: 2025-12-31

Brief Summary

Patients living with diabetes mellitus have double the risk of kidney failure compared to patients without diabetes following use of dye in many x-rays and procedures to diagnose and treat narrowing of the arteries (blood vessels) in the heart that can lead to angina or a heart attack. Heart disease is the commonest cause of death in patients with diabetes. People with diabetes are more likely to need these tests/treatments. By identifying those at greater risk of kidney complications we may be able to make these tests/treatments safer and offer them to more patients with diabetes.

Detailed Description

Diabetes mellitus is an important risk factor for the development of contrast induced nephropathy (CIN), acting as a 'risk multiplier', amplifying the risk of acute kidney injury in these patients. There are important prognostic implications following the development of CIN and it is associated with a significantly increased mortality at 1 year. Diabetes is a major risk factor for coronary disease and these patients often have significant co-morbidities.

Currently creatinine is used to assess risk but this often lags behind clinical status. There is a pressing need for the development of novel, specific biomarkers to improve the detection and treatment of CIN and improve patient outcome in this high risk population.

This is a single centre,study in diabetic patients already undergoing a planned procedure, that is, a percutaneous coronary intervention (PCI). They are patients who are deemed to have an enhanced risk of contrast induced nephropathy by virtue of their diabetic and renal status, the latter being defined by a reduced eGFR which is a marker of renal disease and is based on the creatinine and characteristics of the patient. No additional interventions that are not part of their routine clinical care will be undertaken in these patients. We will be identifying natural biomarkers by obtaining serum and urine samples from these patients.

From a retrospective audit of the cardiac catheter lab database and a review of the literature we have estimated that a sample size of approximately 250 patients with DM and CKD (eGFR < 60 ml/ml) will be needed. We envisage that that we will encounter at least 50 cases of CIN from this cohort. (based on an expected incidence of CIN between 15-30% in this group). Looking for a study rate difference of at least 25%, for power of 95% and confidence intervals of 95% (with Fleiss correction) we will need at least 204 evaluable patients (to avoid Type 2 error). In view of potential drop-out of 10-15% we therefore intend to recruit 250 patients By using C statistics (Receiver operator curve analysis) we will be able to confirm or otherwise that either a particular biomarker or a combination of several biomarkers within 18 hours of procedure will increase the predictive power of CIN developing 72 hours later.

As part of their normal care patients will arrive in hospital on the morning of their planned PCI. They will at some point during the day undergo their PCI. Blood and urine will be taken just prior to the procedure and then at 2 hours, 4 hours, 8 to 12 hours, pre discharge and 3 days after the PCI.

We will then analyse the samples using ELISA techniques and correlate the biomarkers with creatinine to explore which biomarkers or panel of biomarkers may be able to diagnose contrast induced nephropathy earlier than creatinine can currently.

Conditions

Diabetes Mellitus; Renal Impairment

Keywords

Diabetes mellitus; Renal Impairment; Acute Kidney Injury; Coronary revascularisation; eGFR <60ml/min

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetes mellitus, renal impairment

Patients with both diabetes mellitus and eGFR \<60 ml/min

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AKHIL KAPUR

Role: PRINCIPAL_INVESTIGATOR

CONSULTANT CARDIOLOGIST AND HONORARY SENIOR LECTURER, BARTS AND THE LONDON NHS TRUST

KATIE QURESHI

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Fellow/Specialist Registrar, Barts and The London NHS Trust

MAGDI YAQOOB

Role: PRINCIPAL_INVESTIGATOR

PROFESSOR AND CONSULTANT NEPHROLOGIST, HEAD DEPARTMENT OF EXPERIMENTAL MEDICINE AND NEPHROLOGY

Locations

The London Chest Hospital

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

AKHIL KAPUR

Role: CONTACT

Phone: 0208 983 2413

Email: akhil.kapur@bartsandthelondon.nhs.uk

KATIE QURESHI

Role: CONTACT

Phone: 0208 983 2477

Email: katie.qureshi@bartsandthelondon.nhs.uk

Facility Contacts

AKHIL KAPUR

Role: primary

KATIE QURESHI

Role: backup

Other Identifiers

REC 09/H0703/29

Identifier Type: OTHER

Identifier Source: secondary_id

ReDA: 006580 QM

Identifier Type: OTHER

Identifier Source: secondary_id

09/H0703/29

Identifier Type: -

Identifier Source: org_study_id