Contribution of Lung Ultrasound and VExUS Score in Assessment of Volume Status in Maintenance Hemodialysis Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of patients dry weight between the two phases of the study
研究概览
简要总结
This is a prospective, single-arm study that will be conducted over a period of 24 weeks. The same maintenance HD patients will be followed sequentially in two study phases, with each patient serving as their own control.
The study aims to evaluate the role of POCUS, including LUS and VExUS score, in improving the assessment of volume status and determination of dry weight in patients undergoing maintenance HD.
Phase I (Weeks 1-12): Clinical Assessment Phase During the first 12 weeks, all patients will be managed using standard clinical assessment alone. Determination of dry weight and calculation of target ultrafiltration (UF) will rely primarily on clinical parameters, including physical examination and routine clinical judgment.
Phase II (Weeks 13-24): POCUS-guided assessment period During the second 12 weeks, the same patients will undergo POCUS assessment, including LUS and VExUS Score.
LUS and VExUS examinations will be performed 30 minutes after the scheduled hemodialysis session. All measurements will be conducted during the mid-week dialysis session to reflect the average hydration status of each patient.
At the end of each phase, the results of all patients will be correlated with assessment of dry weight by BIS (Inbody version 720).
Inclusion criteria:
ESRD patients on maintenance HD for more than three months. In the HD unit at Medical Research Institute and Faculty of Medicine. Alexandria University.
Age: 25 -65 years old. The ability to give informed consent.
Exclusion criteria:
- Patients with previous echocardiographic evidence of right heart dysfunction, tricuspid valve disease, or IVC thrombosis.
- Patients with liver cirrhosis
- Lung diseases: interstitial lung diseases, COPD patients.
- Obese (BMI≥30) Before inclusion in the study, all patients will be required to fill out a written informed consent. Also, approval from the Medical Ethics Committee will be obtained. Maintenance hemodialysis patients.
详细描述
All study participants will undergo a comprehensive array of assessments
Before the midweek session, which will include the following evaluations:
I. Full history taking and clinical assessment A thorough evaluation will include patient age, gender, cause of ESRD, duration of dialysis, and detailed cardiac and pulmonary medical history, including any intradialytic hypotension or hypertension episodes.
At the end of each mid-week session, blood pressure, pulse oximetry measurement, and respiratory symptoms will be assessed in the 2 phases of the study.
II. Laboratory Investigations:
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESRD patients on maintenance HD for more than three months.
- •In the HD unit at the Medical Research Institute and Faculty of Medicine. Alexandria University.
- •Age: 25 -65 years old.
- •The ability to give informed consent.
排除标准
- •Patients with previous echocardiographic evidence of right heart dysfunction, tricuspid valve disease, or IVC thrombosis.
- •Patients with liver cirrhosis
- •Lung diseases: interstitial lung diseases, COPD patients.
- •Obese (BMI≥30)
结局指标
主要结局
Change of patients dry weight between the two phases of the study
时间窗: 3 months
Change of patient dry weight (in KG ) measured by bioimpedance device between the two phases of the study
次要结局
未报告次要终点
研究者
Sara Taha
Assistant professor of internal medicine
Alexandria University