Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Evaluation of eGFR, Determined by Cystatin C and Creatinine, and mGFR, Measured by Iohexol Clearance, in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04654221
• Other study ID #: QRK509
• Status: Terminated
• Start date: February 21, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: July 2021
• Source: Quark Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 26, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Surgery

Intervention

Diagnostic Test:
• mGFR by iohexol clearance
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance

Locations

Country	Name	City	State
United States	Valley Clinical Trials	Covina	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	CB Flock Research	Mobile	Alabama
United States	Valley Clinical Trials	Northridge	California
United States	Advance Medical Research	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Quark Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between eGFR and mGFR	The primary measure will be the comparison of the P(30) and P(10) between eGFR based on serum cystatin C (eGFRcys) and eGFR based on serum creatinine (eGFRcreat). P(30) and P(10) are defined as the percentage of subjects whose eGFR is within 30% (10%) of the iohexol-based mGFR.	at 90 days post cardiac surgery