Search for New Methods to Detect Acute Renal Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 3 - Any |
| Updated: | 4/5/2019 |
| Start Date: | April 6, 2000 |
| Contact: | Peter S Yuen, Ph.D. |
| Email: | petery@mail.nih.gov |
| Phone: | (301) 402-6702 |
Search for Novel Methods to Detect Acute Renal Failure
The purpose of this study is to find substances in the blood and urine that indicate that a
person has kidney damage. It will identify proteins found only in patients with acute kidney
failure but not in normal healthy people or in patients with volume depletion.
Adults and children who are at least 3 years old who fall into one of the following four
categories may be eligible for this study:
1. Are healthy and have normal kidney function
2. Have volume depletion (this condition differs from acute kidney failure in that it is
easily treated with fluids)
3. Are at high risk of kidney failure
4. Have acute kidney failure (kidney shutdown)
All study participants will have a history and physical examination. Up to four blood samples
of 3 tablespoons each will be taken for laboratory analysis. Urine will be collected for
analysis and to measure urine output. The participants length of stay in the study varies.
People with normal kidney function will be in the study for 1 day and patients with volume
depletion will be studied 3 days. The length of hospitalization of patients at high risk of
kidney failure or in acute kidney failure will depend on the patient s condition and
medication requirements.
The results of this study may lead to the development of earlier and more accurate methods
for diagnosing acute kidney failure. With earlier detection, treatment could be started
earlier, possibly preventing further damage and helping recovery of injury that has already
occurred.
person has kidney damage. It will identify proteins found only in patients with acute kidney
failure but not in normal healthy people or in patients with volume depletion.
Adults and children who are at least 3 years old who fall into one of the following four
categories may be eligible for this study:
1. Are healthy and have normal kidney function
2. Have volume depletion (this condition differs from acute kidney failure in that it is
easily treated with fluids)
3. Are at high risk of kidney failure
4. Have acute kidney failure (kidney shutdown)
All study participants will have a history and physical examination. Up to four blood samples
of 3 tablespoons each will be taken for laboratory analysis. Urine will be collected for
analysis and to measure urine output. The participants length of stay in the study varies.
People with normal kidney function will be in the study for 1 day and patients with volume
depletion will be studied 3 days. The length of hospitalization of patients at high risk of
kidney failure or in acute kidney failure will depend on the patient s condition and
medication requirements.
The results of this study may lead to the development of earlier and more accurate methods
for diagnosing acute kidney failure. With earlier detection, treatment could be started
earlier, possibly preventing further damage and helping recovery of injury that has already
occurred.
The mortality of acute renal failure (ARF) remains high despite advances in supportive care.
There are no established effective drug therapies, and dialysis may promote renal injury via
hypotension or neutrophil activation. Many agents [e.g., mannitol, furosemide, dopamine,
Atrial Natrieuretic Peptide (ANP), Insulin-like Growth Factor (IGF-1), thyroid hormone, etc.]
are effective in animal models but ineffective in treating or preventing human ARF. The
failure of these agents in human ARF may be due to late enrollment into the trial; effective
therapy will likely require earlier detection.
The objective of this clinical study is to identify new biomarkers of renal injury,
progression or recovery by analyzing urinary proteins during ARF. We will enroll patients
with ARF, patients at high risk of ARF, patients with volume depletion, patients with urinary
tract infection, patients with chronic kidney disease, and normal subjects. The diagnosis of
pre-renal versus renal ARF will be made by routine clinical and laboratory testing. The level
of renal dysfunction will be determined by creatinine clearance. Those patients at high risk
for ARF will be followed prospectively and will undergo additional testing if ARF does
develop. Patients will also be studied after creatinine levels return to normal. We will
identify protein and/or microRNA biomarkers that are unique to patients with ARF, but not
found in normal subjects or patients with volume depletion. It is hoped that some of these
proteins may form the basis of new diagnostic tests for ARF.
There are no established effective drug therapies, and dialysis may promote renal injury via
hypotension or neutrophil activation. Many agents [e.g., mannitol, furosemide, dopamine,
Atrial Natrieuretic Peptide (ANP), Insulin-like Growth Factor (IGF-1), thyroid hormone, etc.]
are effective in animal models but ineffective in treating or preventing human ARF. The
failure of these agents in human ARF may be due to late enrollment into the trial; effective
therapy will likely require earlier detection.
The objective of this clinical study is to identify new biomarkers of renal injury,
progression or recovery by analyzing urinary proteins during ARF. We will enroll patients
with ARF, patients at high risk of ARF, patients with volume depletion, patients with urinary
tract infection, patients with chronic kidney disease, and normal subjects. The diagnosis of
pre-renal versus renal ARF will be made by routine clinical and laboratory testing. The level
of renal dysfunction will be determined by creatinine clearance. Those patients at high risk
for ARF will be followed prospectively and will undergo additional testing if ARF does
develop. Patients will also be studied after creatinine levels return to normal. We will
identify protein and/or microRNA biomarkers that are unique to patients with ARF, but not
found in normal subjects or patients with volume depletion. It is hoped that some of these
proteins may form the basis of new diagnostic tests for ARF.
- INCLUSION CRITERIA:
Subjects greater than or equal to 3 years old. Both male and female subjects will be
recruited without regard to race or ethnic origin.
Either:
Normal (creatinine level less than 1.3 mg/DL for adults; creatinine level less than
standard nomogram for children); OR
Oliguria due to volume depletion (indicated by oliguria and Fractional Excretion of Sodium
(FENa) of less than 1%); OR
High risk of ARF, including surgery, transplantation, nephrotoxic antibiotics, or bone
marrow transplant; OR
Evidence of ARF as defined by an acute progressive rise in serum creatinine (at least 50%
increase within 24 hours preceding enrollment) without stabilization or recovery, despite
optimization of hemodynamic fluid status and correction of any known pharmacologic,
pre-renal, or post-renal etiologic factors; OR
Urinary tract infection (to serve as control for ARF studies); OR
Established chronic kidney failure (to serve as control for ARF studies).
EXCLUSION CRITERIA:
Inability to give informed consent or cooperate with the study.
Existence of any other condition which would complicate the implementation or
interpretation of the study.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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