Validation of Serum Creatinine Dosage and Renal Clearance

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 1

Conditions

Kidney Failure

Treatments

Procedure: Measuring serum creatinine

Procedure: Calculation of inuline clearance

Study type

Interventional

Funder types

Other

Identifiers

NCT00323128

2006/037

Details and patient eligibility

About

This study has an open study design. The GFR will be measured using the renal clearance of inulin (Inutest) in volunteers with different stage of renal disease or without renal disease. A blood sample will be obtained for measuring serum creatinine in different laboratories.

Full description

In this study we will investigate the correlation between the GFR as measured by inulin clearance (golden standard) and the estimated GFR as measured by laboratories which used different serum creatinine assays in patients without renal disease and in patients with different stage of kidney failure.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Normal weight as defined by a Body Mass Index of 18 to 30 kg/m2.
Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily.
The subjects must be in stable clinical condition, with stable serum creatinin at least for 6 months.
Persons with different stage of chronic renal disease and without kidney disease (living donors) who need an evaluation of the GFR or Admitted volunteers who easily obtain urine samples.

Exclusion criteria

Transplant patients
Medication that will influence the serumcreatinine.
Morbid obesity
Pregnant, lactating females or females with childbearing potential without adequate contraception (use of oral contraceptives, IUD or condoms with spermicide).
History of allergy or hypersensitivity to inulin
Donation of blood in the 60 days preceding the first visit.
Liver disease, heart failure, nephrotic syndrome.
Patients in critically ill conditions.
Malnutrition
Postrenal kidney failure