The Evaluation of the Influence of the Use of Total Blood Volume Measurement During Dialysis on the Incidence of Intradialytic Hypotension Associated Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- difference in the incidence of intradialytic hypotension-associated adverse events between the intervention and control group
研究概览
简要总结
Establishing the euvolemic state in hemodialysis patients -the so called "dry weight"- is an important clinical conundrum in every nephrologist's daily practice. Underestimation of dry weight (with excessive ultrafiltration) results in dialysis-induced hypotension. Currently used methods to establish dry weight, including clinical assessment, bio-impedance spectroscopy and online relative blood volume (RBV) measurements, all have their limitations. RBV measurement reflects changes in blood volume during dialysis without providing any information about the initial hydration status, or the initial absolute blood volume (ABV). Recently, researchers proposed a new method to calculate ABV, by using the principle of dilution-indicator with RBV measurement. In a small cohort study they identified a total blood volume threshold of 65 millilitres per kilogram dry weight predicting for intra-dialytic hypotension associated symptoms.
The goal of current clinical trial is to re-investigate the accuracy of the above-described method and to confirm the hypothesis of a critical threshold of 65 ml blood volume per kg dry weight in haemodialysis patients. Researchers will compare adjustment of dry weight based on the ABV measurement with standard care to see if dialysis-induced hypotension will be reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Both the patients and the clinicians involved in patient care were not aware of the results of the absolute blood volume measurements.
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
- •hemodialysis patients of three dialysis locations of the Haga Hospital (Zoetermeer, The Hague Leyweg and The Hague Sportlaan).
- •Maintenance hemodialysis, with initiation of treatment predates inclusion in the study by at least 3 months.
- •Hemodialysis scheme three times weekly for four hours
- •Age above 18 years.
排除标准
- •Clinically relevant fistula dysfunction resulting in single poold Kt/V <1,2
- •Severe volume overload with a contraindication to bolus fluid infusion during dialysis according to the treating physician.
- •Severe cardiac dysfunction responsible for >1x intradialytic hypotension associated adverse event /week according to treating physician
- •Severe liver failure with or without presence of ascites
- •More than three hemodialysis sessions per week
- •Single needle treatment
- •Central venous access
- •Residual diuresis > 500 ml/ 24h
- •Inability to provide informed consent
结局指标
主要结局
difference in the incidence of intradialytic hypotension-associated adverse events between the intervention and control group
时间窗: 10 weeks
The incidence of intradialytic hypotension-associated adverse events (IHAAE) will be compared at baseline and after intervention, using questionnaires. Participants will undergo a 4-week run-in period to assess baseline incidence. The incidence of IHAAE will be calculated by dividing the number of dialysis treatments with one or more symptoms attributable to IHAAE as a percentage of the total number of dialysis treatments with a completed questionnaire. After randomization and the intervention, the occurence of IHAAE will be measured in both arms for another four weeks. Differences in incidence of IHAAE between groups will be analyzed using ANCOVA, adjusting for baseline IHAAE, pre-dialysis blood pressure and the use of anti-hypertensive agents. IHAAE is defined as a systolic blood pressure \< 90 mmHg Either symptomatic or asymptomatic, or solely symptoms associated to (impeding) hypotension like dizziness, lightheadedness, sweating, cramps or visuel disturbances.
次要结局
- Reproducibility of absolute blood volume measurement(2 weeks)
- Sensitivity, specificity(10 weeks)
- Baseline incidence of intradialytic hypotension associated adverse events (IHAAE) in the entire study population.(baseline)
- Correlation of absolute blood volume measurement with other diagnostic tests to determine blood volume(2 weeks)
- positive predictive value, negative predictive value(10 weeks)
研究者
Louis Jean Vleming
dr. LJ Vleming
HagaZiekenhuis