Evaluation of the Performance of GFR Estimating Equations in HIV Positive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Performance of Glomerular Filtration Rate (GFR) Estimating Equations
研究概览
简要总结
Current methods to assess kidney function have not been tested in people who have HIV/AIDS population. Given effects of the disease as well as potential effects of the medications, it is possible that the methods currently used to assess kidney function are not accurate. This purpose of this study is to evaluate methods to assess kidney function the HIV population. The investigators hypothesize that tenofovir causes a decrease in the secretion of creatinine which would cause an elevation in blood levels without affecting actual glomerular filtration rate (GFR).
详细描述
General description: The overall study procedure requires assessment of eligibility and safety for inclusion in the study (through a "screening questionnaire" and "health screening visit") and if eligible, a one day study visit ("Study visit").
Screening questionnaire All subjects, whether they are interviewed during a clinic visit or call in response to fliers, will be give 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, as described in Table 4.
- 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
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years of age or older
- •Confirmed HIV positive status
- •Treatment with stable antiretroviral medications for a period of at least 3 months prior to the study
排除标准
- •Persons less than 18 years of age. Children are excluded due to the fact that they are still growing. Growth causes levels of creatinine to change differently than in adults, thus requiring the use of age-specific GFR estimating equations.
- •Women who are either pregnant or who intend to become pregnant during the period of time in which the study visits will occur.
- •Allergy to any of the contrast media used or a known allergy to iodine or shellfish. Subjects who are not sure if they have an iodine allergy because they have not eaten shellfish nor have never received contrast dye will be excluded from participation.
- •Inability to cease taking medications that affect creatinine levels (e.g. trimethoprim containing medications, cimetidine) for one week prior to the study visit
- •Inability to maintain stable regimen of non-steroidal anti-inflammatory agents, angiotension converting enzyme inhibitors and or angiotension receptor blockers for one week prior to study visit.
- •Women who are breastfeeding
- •Current treatment with amiodarone
- •Current treatment with metformin
- •Acute exacerbation of asthma or chronic obstructive lung disease in the past three months requiring hospitalization or oral steroid therapy
- •Inadequate venous access
- •People with kidney failure (currently undergoing or having received peritoneal dialysis or hemodialysis treatment within the past three months or estimated GFR (eGFR) < 15 ml/min per 1.73 m2)
- •End stage conditions such as cirrhosis
- •Active treatment for cancer
- •Progressive neurological diseases
- •Severe gastric immotility
- •History of cognitive or physical impairments that will not allow completion of the study
- •Inability to provide informed consent
结局指标
主要结局
Performance of Glomerular Filtration Rate (GFR) Estimating Equations
时间窗: Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose.
Overall bias, median difference (95% confidence interval), mL/min per 1.73 m\^2, assessed as the median difference between the measured and estimated GFR across all estimated GFR levels, with positive values indicating an underestimation of measured GFR.
次要结局
未报告次要终点
