Concordance and Discordance in the Assessment of Volume Status in Home Dialysis Patients: A Comparison of Modified Medical Research Council Dyspnea Scale, Physical Exam, and Point of Care Ultrasound (POCUS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Agreement between the LUS and physical exam
研究概览
简要总结
Fluid overload (when the body has too much fluid), is one of the reasons why people on home dialysis need to go to the hospital. Fluid overload commonly presents as trouble breathing and leg swelling. Traditionally, doctors check for this by asking patients if they have any symptoms like leg swelling or shortness of breath and by doing a physical exam which includes listening to the lungs or looking for swelling in legs. However, a newer, safe, and non-invasive method called point-of-care ultrasound (POCUS) has become very popular. However, there is not a lot of research yet on how POCUS and LUS (lung ultrasound) specifically help home dialysis patients, including those on peritoneal dialysis or home hemodialysis. Peritoneal dialysis is a way to clean the blood by putting a special fluid into the abdomen through a small tube. The fluid uses the natural lining of the belly as a filter to remove waste and extra water. Home hemodialysis is a treatment where a machine acts like an artificial kidney to clean the blood. Patients get trained to do this themselves at home by connecting to the machine with a couple of needles, which cleans their blood of waste and extra fluid. POCUS, especially a (LUS), has been shown to be useful for dialysis patients in outpatient units.
This study will compare different 3 different methods of detecting fluid overload in adult patients with End-stage kidney disease who are receiving home dialysis: answering various survey questions, completing a physical exam, and a LUS. The study seeks to determine which of these methods is the best method to determine fluid overload.
详细描述
Participants will undergo the following assessments or procedures:
- Review of medical records, including those from the dialysis center.
- Blood pressure and weight measurement
- Rate breathlessness
- Physical Exam
- Ultrasound procedure, during which the participant will lie flat on their back with their chest exposed. A small amount of gel will be applied to the skin, and a handheld ultrasound device will be pressed lightly to the chest. Eight specific areas on the chest will be imaged (four on each side) to look for something called "B-lines," which can show if there's extra fluid in your lungs. This ultrasound part of the visit should only take about 10 to 15 minutes in total.
Care will be taken to expose only the area being scanned. A chaperone (someone else in the room) will be present for all female patients. All male patients will be asked if they want a chaperone. If they say yes, a chaperone will be present during the ultrasound procedure. After the ultrasound, study participation is complete.
We expect the entire study from enrollment to the completion of data collection for all subjects, to last 9 months. However, each participant will complete a single study visit, which will last for approximately 30-60 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age: Greater than 18 years.
- •Diagnosis: End-stage kidney disease (ESKD).
- •Treatment: Receiving home dialysis, either peritoneal dialysis (PD) or home hemodialysis (HHD).
- •Duration of Home Dialysis: At least three months on home dialysis.
排除标准
- •Consent: Inability to provide informed consent.
- •Inclusion Criteria: Not meeting any of the inclusion criteria.
- •Urgent-Start PD.
- •Any other obvious cause of shortness of breath not related to volume overload including but not limited to pneumonia, pneumothorax, advanced COPD and Interstitial lung disease.
结局指标
主要结局
Agreement between the LUS and physical exam
时间窗: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Researchers will measure discordance and concordance between the LUS and physical exam. A pair is concordant if the observation ranking higher on one variable also ranks higher on the second measure. The pair is discordant if the observation ranking higher on one endpoint measure and ranks lower on the other. The pair is tied if the subjects have the same classification on both measures.
Agreement between the LUS and mMRC dyspnea scale
时间窗: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Researchers will measure discordance and concordance between the LUS and mMRC dyspnea scale. A pair is concordant if the observation ranking higher on one variable also ranks higher on the second measure. The pair is discordant if the observation ranking higher on one endpoint measure and ranks lower on the other. The pair is tied if the subjects have the same classification on both measures.
Agreement between the physical exam and mMRc dyspnea scale.
时间窗: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Researchers will measure discordance and concordance between the physical exam and mMRc dyspnea scale. A pair is concordant if the observation ranking higher on one variable also ranks higher on the second measure. The pair is discordant if the observation ranking higher on one endpoint measure and ranks lower on the other. The pair is tied if the subjects have the same classification on both measures.
Discordance and concordance between the LUS and physical exam, the LUS and mMRC dyspnea scale, and between the physical exam and mMRc dyspnea scale.
时间窗: 6-12 months
We will measure discordance and concordance between the LUS and physical exam, the LUS and mMRC dyspnea scale, and between the physical exam and mMRc dyspnea scale. A pair is concordant if the observation ranking higher on one variable also ranks higher on the second measure. The pair is discordant if the observation ranking higher on one endpoint measure and ranks lower on the other. The pair is tied if the subjects have the same classification on both measures. Depending on the results additional analyses may be conducted to determine differences between peritoneal dialysis and home hemodialysis, or differences by sex, or differences by those on or off diuretics on those with and without residual renal function assessed by 24 hour urine output routinely done as part of standard care for the PD patients
discordance and concordance between the LUS and physical exam, the LUS and mMRC dyspnea scale, and between the physical exam and mMRc dyspnea scale.
时间窗: Each participant will be involved in the study for 30-60 minutes which will include the questionnaire, physical examination, blood pressure, weight and ultrasound procedure.
A pair is concordant if the observation ranking higher on one variable also ranks higher on the second measure. The pair is discordant if the observation ranking higher on one endpoint measure and ranks lower on the other. The pair is tied if the subjects have the same classification on both measures.
次要结局
- Correlation of mMRC dyspnea scale and blood pressure(Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed)
- Correlation of mMRC dyspnea scale and weight(Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed)
- Correlation of LUS and blood pressure(Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed)
- Correlation of LUS and weight(Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed)
- Correlation of physical exam and blood pressure(Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed)
- Correlation of physical exam and weight(Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed)
研究者
Nupur Gupta
Associate Professor of Clinical Medicine
Indiana University