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Search for New Methods to Detect Acute Renal Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00026702
Recruitment Status : Recruiting
First Posted : November 15, 2001
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Tracking Information
First Submitted Date November 14, 2001
First Posted Date November 15, 2001
Last Update Posted Date July 9, 2020
Actual Study Start Date June 7, 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: July 1, 2020)
estimated GFR [ Time Frame: at the time of sample collection ]
Serum creatinine will be measured and eGFR will be calculated
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Search for New Methods to Detect Acute Renal Failure
Official Title Search for Novel Methods to Detect Acute Renal Failure
Brief Summary

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.

Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population subjects with and without kidney disease, can include vulnerable populations such as pregnant women, cognitively impaired adults, or NIH employees
Condition
  • Kidney Disease
  • Kidney Failure
  • Kidney Failure, Chronic
  • Healthy Volunteers
  • Renal Tubular Toxicity
Intervention Not Provided
Study Groups/Cohorts All
Subjects at least three years old
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 18, 2008)
640
Original Enrollment
 (submitted: June 23, 2005)
720
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Peter S Yuen, Ph.D. (301) 402-6702 petery@mail.nih.gov
Contact: Robert A Star, M.D. (301) 496-6325 starr@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00026702
Other Study ID Numbers 000107
00-DK-0107
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators Not Provided
Investigators
Principal Investigator: Robert A Star, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date June 30, 2020