Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery

Quark Pharmaceuticals

Status: Terminated

Conditions: Cardiac Surgery

Treatments: Diagnostic Test: mGFR by iohexol clearance

Study type: Observational

Funder types: Industry

Identifiers

NCT04654221

QRK509

Details and patient eligibility

About

To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute kidney injury (AKI) approximately 90 days following cardiac surgery

Full description

This is an open label, single-visit study to evaluate the relationship between mGFR and eGFR based either on serum creatinine (eGFRcreat) or cystatin C (eGFRcys) approximately 90 days following cardiac surgery. No investigational study drug will be administered.

Enrollment: 16 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female, age ≥ 45 years old

• At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:

  1. Reduced renal function
  2. Diabetes with ongoing insulin treatment
  3. Albuminuria

• Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest

Key Exclusion Criteria:

• Emergent surgeries, including aortic dissection, and major congenital heart defects
• Past cardiac surgery off CPB
• Have a known allergy to iohexol

Trial design

16 participants in 6 patient groups

Male, BMI <= 24.9

Description:

Male subjects with a BMI of less than or equal to 24.9

Treatment:

Diagnostic Test: mGFR by iohexol clearance

Female, BMI <= 24.9

Description:

Female subjects with a BMI of less than or equal to 24.9

Treatment:

Diagnostic Test: mGFR by iohexol clearance

Male, BMI 25-29

Description:

Male subjects with a BMI of 25 to 29

Treatment:

Diagnostic Test: mGFR by iohexol clearance

Female, BMI 25-29

Description:

Female subjects with a BMI of 25 to 29

Treatment:

Diagnostic Test: mGFR by iohexol clearance

Male, BMI >29

Description:

Male subjects with a BMI of greater than 29

Treatment:

Diagnostic Test: mGFR by iohexol clearance

Female, BMI >29

Description:

Female subjects with a BMI of greater than 29

Treatment:

Diagnostic Test: mGFR by iohexol clearance