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Protocol Details

Search for Novel Methods to Detect Acute Renal Failure

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

00-DK-0107

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Acute Kidney Injury

Recruitment Keyword(s)

None

Condition(s)

Kidney Disease;
Kidney Failure;
Kidney Failure, Chronic;
Healthy Volunteers;
Renal Tubular Toxicity

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

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Eligibility

INCLUSION CRITERIA:

1. Subjects >= 3 years old. Both male and female subjects will be recruited without regard to race or ethnic origin.

2. Either:

a) Normal (creatinine level < 1.3 mg/dl for adults; creatinine level < standard nomogram for children), OR

b) Oliguria due to volume depletion (indicated by oliguria and Fractional Excretion of Sodium (FENa) of less than 1%), OR

c) High risk of ARF, including surgery, transplantation, nephrotoxic antibiotics, or bone marrow transplant. OR

d) 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

e) Urinary tract infection (to serve as control for ARF studies), OR

f) 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert A. Star, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 2DEM RM 6119
6707 DEMOCRACY BLVD
BETHESDA MD 20817
(301) 496-6325
starr@mail.nih.gov

Peter S. Yuen, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 3N108
10 Center Drive
Bethesda, Maryland 20892
(301) 402-6702
petery@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00026702

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