Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04654221

Enrollment

Registered

2020-12-04

Start date

2020-02-21

Completion date

2021-03-26

Last updated

2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

GFR, Acute Kidney Injury, AKI

Brief 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

Detailed 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.

Interventions

DIAGNOSTIC_TESTmGFR by iohexol clearance

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between eGFR and mGFR	at 90 days post cardiac surgery	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026