Non-invasive Assessment to Predict Tolerance to Fluid Removal on Intermittent Kidney Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Intradialytic hypotensive event in the peri-dialytic or post-dialytic period
研究概览
简要总结
This prospective cohort study aim to investigate the ability of multiple types of assessments including 1) the modified Venous Excess Ultrasound (VExUS) assessment, 2) non-invasive estimation of absolute blood volume (ABV), and 3) change in carotid Doppler at the start of IKRT to predict IDHE in acutely ill hospitalized patients. The secondary aim will be to determine whether each modality improves the prediction of IHDE compared to the evaluation of the attending physician and whether they also predict cerebral hypoxia during IKRT measured by near-infrared spectroscopy (NIRS). Finally, detailed hemodynamic data including relative blood volume monitoring, tissue oximetry, and other parameters will be collected continuously during IKRT sessions enabling exploratory analyses aimed at identifying hemodynamic phenotypes related to IDHE during IKRT.
详细描述
Background:
Fluid accumulation and intra-dialytic hypotensive events (IDHE) are independently associated with worse prognosis in patients undergoing intermittent kidney replacement therapy (IKRT), both in the setting of acute kidney injury (AKI) and in patients with end-stage kidney disease (ESKD). An optimal IKRT prescription needs to achieve adequate fluid homeostasis while mitigating the risk of IDHE. However, predicting tolerance to fluid removal is challenging, particularly in acutely ill hospitalized patients in whom intravascular volume and compensatory mechanisms are affected by the presence of acute illness.
The following modalities will be investigated in this study to determine if they predict IDHE during hemodialysis in hospitalized patients:
- The modified VExUS assessment before the hemodialysis session
- Estimation of absolute blood volume during the hemodialysis session
- Removed in protocol version 2.0: Change in carotid Doppler parameters in response to fluid administration at the start of hemodialysis
Objectives:
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
- •Adult patient ≥18 year-old
- •Hospitalized at the CHUM in the intensive care unit (ICU) or general ward
- •Receiving or planned ≥3x/week IKRT treatments
- •Planned on-line hemodiafiltration (HDF) or hemodialysis (HD) sessions with ≥1L of fluid removal per session
排除标准
- •Planned hospital discharge, death, or transition to comfort care within 48 hours according to the attending physician
- •End of active care (awaiting hospital discharge)
结局指标
主要结局
Intradialytic hypotensive event in the peri-dialytic or post-dialytic period
时间窗: From the initiation of dialysis to 15 minutes after dialysis
Intradialytic hypotension will be defined as a drop in systolic blood pressure below 90 mmHg which requires an intervention (dialysis interruption, vasopressor initiation or dosage increase, fluid bolus, interruption of net ultrafiltration, change in body position with therapeutic intent) In patients with a baseline below 90 mmHg, it will be defined as a decrease of more than 10 mmHg from baseline systolic blood pressure.
次要结局
- Rate of intradialytic hypotension(From enrolment to 14 days)
- Mortality rate(From enrolment to 90 days)
- Intradialytic cerebral desaturation events(From the initiation of dialysis to 15 minutes after dialysis)