Evaluation of New Test Method to Measure Kidney Function
Validation of Fast Methods to Measure Glomerular Filtration Rate
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 0.5 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.
調査の概要
状態
条件
詳細な説明
研究の種類
入学
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
INCLUSION CRITERIA:
Both male and female subjects will be recruited without regard to race or ethnic origin.
Suspected renal dysfunction based upon:
Acute renal failure with elevated 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
Congestive heart failure by clinical criteria (rales, S3, pedal edema on clinical exam), or
Edema or ascites (by clinical exam), or
Sepsis or septic physiology (shock or hyperdynamic circulation, suspected sepsis), or
Chronic Renal Failure (creatinine greater than 1.3).
Patients older than 18 years old who provide their own informed consent.
Patients younger than 18 but at least 6 years old whose parent or legal guardian can provide informed consent.
EXCLUSION CRITERIA:
Inability to cooperate with the study.
Known allergy to iothalamate or other iodine containing compounds.
Urinary tract obstruction.
Pregnant women or lactating mothers.
Patients in whom vascular access cannot be secured.
研究計画
研究はどのように設計されていますか?
協力者と研究者
出版物と役立つリンク
一般刊行物
- Perrone RD, Steinman TI, Beck GJ, Skibinski CI, Royal HD, Lawlor M, Hunsicker LG. Utility of radioisotopic filtration markers in chronic renal insufficiency: simultaneous comparison of 125I-iothalamate, 169Yb-DTPA, 99mTc-DTPA, and inulin. The Modification of Diet in Renal Disease Study. Am J Kidney Dis. 1990 Sep;16(3):224-35. doi: 10.1016/s0272-6386(12)81022-5.
- Levey AS, Greene T, Schluchter MD, Cleary PA, Teschan PE, Lorenz RA, Molitch ME, Mitch WE, Siebert C, Hall PM, et al. Glomerular filtration rate measurements in clinical trials. Modification of Diet in Renal Disease Study Group and the Diabetes Control and Complications Trial Research Group. J Am Soc Nephrol. 1993 Nov;4(5):1159-71. doi: 10.1681/ASN.V451159.
- Coresh J, Toto RD, Kirk KA, Whelton PK, Massry S, Jones C, Agodoa L, Van Lente F. Creatinine clearance as a measure of GFR in screenees for the African-American Study of Kidney Disease and Hypertension pilot study. Am J Kidney Dis. 1998 Jul;32(1):32-42. doi: 10.1053/ajkd.1998.v32.pm9669421.
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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