Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026715
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-11-14
Brief Title:
Evaluation of New Test Method to Measure Kidney Function
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Validation of Fast Methods to Measure Glomerular Filtration Rate
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the accuracy of a new Fast GFR glomerular filtration rate test to evaluate kidney function Accurate assessment of kidney function is important in many clinical situations including detecting kidney disease early determining appropriate drug dosages deciding when to begin dialysis and evaluating heart and kidney organ donors and recipients The current GFR test is used mostly for research purposes as it is too costly and complicated for general medical use Another significant drawback to its use in diagnosing acute kidney failure is the time it takes 3 to 24 hours to complete since effective therapy for this condition requires its detection as soon as possible The Fast GFR by comparison takes only 45 minutes
Patients 6 years old and older with kidney disease or with impaired kidney function caused by abnormal heart function or swelling-from congestive heart failure severe infections swelling from fluid accumulation fluid in the abdomen or burns-may be eligible for this study Patients will undergo both the standard and the Fast GFR tests described below to evaluate the accuracy of the new test
Fast GFR Two catheters thin flexible tubes are placed into two arm veins one for injecting iothalamate-an agent commonly used in CT scanning and blood vessel imaging-and the other for collecting blood samples Baseline blood and urine samples are collected and then 05 milliliter ml iothalamate is injected into a vein Blood samples are collected at 5 10 15 20 30 and 45 minutes in adults and at 5 15 and 45 minutes in children Urine is collected at 45 minutes The size of the bladder is measured using ultrasound to determine if the bladder has completely emptied
Standard GFR Iothalamate 1 ml is injected under the skin Blood samples are collected at 60 90 120 180 and 240 minutes A heparin lock is used to avoid multiple needle sticks Urine is collected at 60 90 120 180 and 240 minutes The size of the bladder is measured using ultrasound to determine if the bladder has completely emptied
Patients 6 years old and older with kidney disease or with impaired kidney function caused by abnormal heart function or swelling-from congestive heart failure severe infections swelling from fluid accumulation fluid in the abdomen or burns-may be eligible for this study Patients will undergo both the standard and the Fast GFR tests described below to evaluate the accuracy of the new test
Fast GFR Two catheters thin flexible tubes are placed into two arm veins one for injecting iothalamate-an agent commonly used in CT scanning and blood vessel imaging-and the other for collecting blood samples Baseline blood and urine samples are collected and then 05 milliliter ml iothalamate is injected into a vein Blood samples are collected at 5 10 15 20 30 and 45 minutes in adults and at 5 15 and 45 minutes in children Urine is collected at 45 minutes The size of the bladder is measured using ultrasound to determine if the bladder has completely emptied
Standard GFR Iothalamate 1 ml is injected under the skin Blood samples are collected at 60 90 120 180 and 240 minutes A heparin lock is used to avoid multiple needle sticks Urine is collected at 60 90 120 180 and 240 minutes The size of the bladder is measured using ultrasound to determine if the bladder has completely emptied
Detailed Description:
Accurate measurement of renal function is required to detect and treat renal dysfunction The glomerular filtration rate GFR is the most widely used test to measure renal function in research studies However current GFR tests are lengthy costly and too complicated for general use in clinical settings At the present time therapies for acute renal failure are generally unsatisfactory However it is likely that effective therapy will need to be given early in the course of acute renal failure We recently developed a simple Fast intravenous GFR test that can be performed in 45 minutes that may assist in identification of patients with the earliest stages of acute renal failure This test has been validated in ambulatory adults with chronic renal failure The current protocol will compare the fast intravenous GFR test to a reference standard subcutaneous GFR method in patients with acute renal failure sepsis congestive heart failure edema or chronic renal failure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-DK-0148 | None | None | None |