Epidemiologic Characteristics And Risk Factors Of Intradialytic Hypotension In Maintenance Hemodialysis Patients: A Prospective Multicenter Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Incidence Of Intradialytic Hypotension During A Single Maintenance Hemodialysis Session
研究概览
简要总结
This prospective, multicenter observational study aims to describe how often intradialytic hypotension (IDH) occurs and to identify its risk factors in adult patients receiving maintenance hemodialysis. Intradialytic hypotension is a common complication during dialysis that can lead to symptoms, organ hypoperfusion, and interruption of treatment.
Participants will be adults on regular maintenance hemodialysis who meet predefined inclusion and exclusion criteria. Routine clinical information will be collected, including demographics, primary kidney disease, comorbidities, medications, dialysis vintage, dialysis prescription (ultrafiltration volume and rate, dialysate composition, treatment time), and standard laboratory tests. During a defined observation period, blood pressure and related symptoms will be recorded across dialysis sessions to document the frequency, severity, and patterns of IDH.
The main goals are to estimate the incidence and prevalence of intradialytic hypotension in maintenance hemodialysis patients and to explore potential risk factors, such as patient characteristics, cardiovascular status, volume status, and dialysis-related parameters. The findings may help clinicians better recognize patients at high risk of IDH and optimize dialysis prescriptions and monitoring strategies to reduce the occurrence of IDH and its adverse consequences.
详细描述
This is a prospective, multicenter, observational study designed to characterize the epidemiology and risk factors of intradialytic hypotension (IDH) in adult patients undergoing maintenance hemodialysis. No study-specific interventions will be assigned; all dialysis treatments and medical therapies will be conducted according to routine clinical practice at each participating center.
Eligible participants are adults receiving thrice-weekly or regular maintenance hemodialysis for end-stage kidney disease. After obtaining informed consent (as required by local regulations), baseline data will be collected from the medical record and patient interview. Baseline variables will include:
Demographics (age, sex, body mass index, smoking status) Primary kidney disease and dialysis vintage Comorbidities (e.g., diabetes mellitus, hypertension, cardiovascular disease, heart failure, arrhythmia) Usual medications, with a focus on antihypertensive agents, diuretics, and cardiovascular drugs Pre-dialysis clinical parameters (weight, dry weight, interdialytic weight gain, pre-dialysis blood pressure) Routine laboratory values (e.g., hemoglobin, albumin, electrolytes, calcium-phosphate metabolism indices, markers of inflammation and nutrition, as available) Dialysis prescription and treatment-related parameters will be documented, including dialyzer type, blood flow rate, dialysate flow, dialysate composition (sodium, calcium, bicarbonate), treatment duration, and planned and achieved ultrafiltration volume and ultrafiltration rate.
During the observation period (covering a predefined number of consecutive dialysis sessions per patient), blood pressure will be monitored according to local standard practice (for example, before dialysis, at regular intervals during dialysis, and at the end of treatment). Episodes of intradialytic hypotension will be identified using a pre-specified definition (e.g., absolute blood pressure thresholds and/or drop from baseline, with or without associated symptoms), which will be applied consistently across all centers. When feasible, associated symptoms (such as dizziness, cramps, chest discomfort, nausea) and interventions (e.g., reduction or cessation of ultrafiltration, saline infusion, change in dialysate temperature, adjustment of position, or early termination of dialysis) will be recorded.
The primary analyses will describe:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults (≥18 years) with end-stage renal disease on maintenance hemodialysis
- •Receiving thrice-weekly (or routine) in-center hemodialysis for ≥3 months before enrollment
- •Scheduled for a standard hemodialysis session of approximately 3-5 hours on the study day
- •Able to provide informed consent (or via legally authorized representative, if applicable)
排除标准
- •Acute medical instability precluding observation of a routine dialysis session (e.g., active sepsis requiring vasopressors, uncontrolled arrhythmias)
- •Recent acute coronary syndrome or stroke within 3 months
- •Pre-dialysis systolic blood pressure <90 mmHg on the study day before starting dialysis
- •Ongoing active major bleeding or anticipated urgent transfusion during the session
- •Pregnancy
- •Participation in an interventional trial expected to alter intradialytic blood pressure during the observed session
研究组 & 干预措施
Maintenance Hemodialysis Cohort
Adults with end-stage renal disease receiving routine maintenance hemodialysis at participating centers. Prospective observation over approximately 3 months; no study-assigned interventions. Standard dialysis care per local practice. Data collected include demographics, comorbidities, medications, dialysis vintage, prescription (UF volume/rate, dialysate sodium/calcium/bicarbonate, temperature, treatment time), blood pressure before/during/after dialysis, IDH symptoms, and clinical responses (e.g., UF reduction, saline, cooling). Routine labs as available.
结局指标
主要结局
Incidence Of Intradialytic Hypotension During A Single Maintenance Hemodialysis Session
时间窗: From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).
Proportion of enrolled maintenance hemodialysis patients who experience intradialytic hypotension (IDH) during one observed hemodialysis session. IDH is defined as a decrease in systolic blood pressure (SBP) by 20-40 mmHg from pre-dialysis or during dialysis, with or without related symptoms, according to pre-specified criteria.
次要结局
- Incidence Of Asymptomatic IDH(From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).)
- Distribution Of Time To Onset Of Intradialytic Hypotension(From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).)
- Association Between Pre-Dialysis Mean Arterial Pressure And IDH(From pre-dialysis blood pressure assessment immediately before the session to the end of the same hemodialysis session (approximately 3.5-4 hours).)
- Association Between Interdialytic Weight Gain And IDH(From the pre-dialysis weight assessment immediately before the session to the end of the same hemodialysis session (approximately 3.5-4 hours).)
- Association Between Pre-Dialysis Serum Potassium And IDH(Based on the most recent pre-dialysis serum potassium value within 3 months prior to the observed session and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).)
- Association Between Serum Albumin And IDH(Based on the most recent serum albumin measurement within 3 months prior to the observed session and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).)
- Predictive Performance Of Traditional Clinical Indicators For IDH(Based on baseline measurements (collected within 3 months before the observed session or immediately pre-dialysis) and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).)
研究者
Qiancheng Xu
Principal Investigator
First Affiliated Hospital of Wannan Medical College