Validity and Reliability of a Novel GFR Marker
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Accuracy and precision of the different markers for measuring GFR
研究概览
简要总结
Glomerular filtration rate (GFR) is widely accepted as the best index of kidney function in health and disease, and accurate values are required for optimal clinical decision making and in large-scale epidemiologic studies and clinical trials. Current recommended methods for measuring GFR are expensive, cumbersome to administer and assay and requires urine collection and administration of radioactive materials. The purpose of this study is to evaluate two non-radioactive markers (iohexol and gadolinium) compared to urinary clearance of inulin and iothalamate. The investigators hypothesize that plasma clearance of non-radioactive markers will be unbiased compared to a gold standard and more precise than currently used urinary clearance methods.
详细描述
General description: The overall study procedure requires assessment of eligibility and safety for inclusion in the study through a) the screening questionnaire; b) medical history, which will be derived from subject and combined with a review of his/her medical record after signing the consent; and c) interview, physical examination and laboratory tests from screening visit if required.
Screening questionnaire: All subjects, whether they are interviewed during a clinic visit or call in response to fliers, will be given the pre-screening questionnaire. This will be given to people who voluntarily express interest in the study. Participants who do not disclose any conditions that would exclude them from participating will be invited to a health screening visit.
Health screening visit: The purpose of the pre-study health screening is to perform a more detailed assessment than is provided in the screening questionnaire to determine if potential subjects are eligible to participate in the study. A member of the research team will first read the consent form with the subject, describe the health screening and study visits, and answer any questions that the subject has regarding the nature of the study and/or study procedures. The screening visit will consist of the following:
- Reading and signing the study consent. The subject will be given a copy of the consent.
- Collection of information on demographics and current and past health history.
- Ascertain participants medical history through participant interview and a review of his/her medical record
- A physical exam, which will include measuring and recording vital signs (temperature, blood pressure, heart rate, breathing rate), height, weight (if not documented in medical record in past 3 months).
- Collection of a blood sample for laboratory testing, if required.
- Pre-menopausal women of child-bearing potential we will undergo a serum pregnancy test, using a small amount of blood from the sample collected above.
- Ascertainment of current and recent past medications.
If the subject is a patient at Tufts Medical Center, a research team member may access the potential participant's medical record after the subject has signed the consent form to further screen for potential exclusion criteria, ascertain laboratory test results that are necessary for determining eligibility, and confirm the medical history provided by the potential participant and medication list. If the participant is not a patient at Tufts Medical Center, then the research team member will obtain permission to obtain the participant's medical record from his/her physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female.
- •Older than 18 years of age.
- •With and without known CKD - for the purpose of this study, CKD will be defined on the basis by prior diagnosis of CKD, urologic or kidney disease, known abnormal urinalysis, or history of having seen a nephrologist.
排除标准
- •Currently undergoing or having received peritoneal dialysis or hemodialysis treatment within the past three months. Subjects with an eGFR < 30 mL/min/1.73 m2 will not receive Magnevist during the study visit.
- •Active pulmonary edema.
- •Class III or IV congestive heart failure.
- •History of urinary retention or current urinary incontinence.
- •Inability to cease taking medications that affect creatinine levels (e.g., bactrim, cimetidine) for one week prior to the study visit.
- •Inability to maintain a stable regimen of anti-inflammatory agents and angiotensin converting enzyme inhibitors for one week prior to study visit
- •Current treatment with amiodarone or metformin.
- •Acute exacerbation of asthma or chronic obstructive lung disease in the past three months requiring hospitalization or oral steroid therapy.
- •Inadequate venous access.
- •End stage conditions such as cirrhosis.
- •Active treatment for cancer.
- •Progressive neurological diseases.
- •Severe gastric immotility.
- •Recent radiation exposure to γ-emitting isotope other than technetium
- •Known allergy to any of the GFR markers, iodine, or shellfish. Subjects who are not sure if they have an iodine allergy because they have not eaten shellfish or have never received contrast dye will be excluded from participation.
- •Dermatitis herpetiformis.
- •Hypocomplementemic vasculitis.
- •Multinodal goiter.
- •Graves' disease.
- •Autoimmune thyroiditis.
- •Cognitive or physical impairments that will prevent a subject from providing informed consent.
- •History of mastectomy.
- •Hemoglobin levels below 10 g/dL.
- •Women who are either pregnant or who intend to become pregnant during the period of time in which the study visits will occur.
研究组 & 干预措施
With and without Chronic Kidney Disease
A cohort of 10 patients subjects with and without kidney disease exhibiting a broad range of age and kidney function
干预措施: Inulin (Drug)
结局指标
主要结局
Accuracy and precision of the different markers for measuring GFR
时间窗: End points are not applicable. It's a cross-sectional design study
次要结局
未报告次要终点