Finding new ways to detect acute kidney failure
Search for Novel Methods to Detect Acute Renal Failure
National Institutes of Health Clinical Center (CC) · NCT00026702
This study is trying to find new markers in blood and urine that can help identify kidney damage early in people, including those with acute kidney failure and those at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 640 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00026702 on ClinicalTrials.gov |
What this trial studies
This study aims to identify substances in blood and urine that indicate kidney damage, specifically focusing on proteins unique to patients with acute kidney failure. Participants will include healthy individuals, those with volume depletion, high-risk patients, and those with acute kidney failure. The study will involve collecting blood and urine samples for laboratory analysis to discover biomarkers associated with renal injury. By improving early detection, the study hopes to enhance treatment outcomes for acute renal failure.
Who should consider this trial
Good fit: Ideal candidates include adults and children aged 3 and older who are healthy, have volume depletion, are at high risk of kidney failure, or have acute kidney failure.
Not a fit: Patients with stable chronic kidney disease who do not experience acute changes in their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of acute kidney failure, potentially improving patient outcomes and treatment options.
How similar studies have performed: Other studies have explored biomarkers for kidney injury, but this approach focuses specifically on acute renal failure, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:
1. Subjects \>= 3 years old. Both male and female subjects will be recruited without regard to race or ethnic origin.
2. Either:
1. Normal (creatinine level \< 1.3 mg/dl for adults; creatinine level \< standard nomogram for children), OR
2. Oliguria due to volume depletion (indicated by oliguria and Fractional Excretion of Sodium (FENa) of less than 1%), OR
3. High risk of ARF, including surgery, transplantation, nephrotoxic antibiotics, or bone marrow transplant. OR
4. 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
5. Urinary tract infection (to serve as control for ARF studies), OR
6. Established chronic kidney disease (to serve as control for ARF studies).
EXCLUSION CRITERIA:
1. Minors who do not give clear assent, even with parental consent
2. Existence of any other condition which would complicate the implementation or interpretation of the study.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Robert A Star, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Peter S Yuen, Ph.D.
- Email: petery@mail.nih.gov
- Phone: (301) 402-6702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Disease, Kidney Failure, Kidney Failure, Chronic, Healthy Volunteers, Renal Tubular Toxicity, Acute Kidney Injury