Inferior Vena Cava and Lung Ultrasound B-lines Guided Decongestion in Critically Ill Kidney Failure Patients With Heart Failure: a Single-center, Prospective, Randomized Controlled Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in pulmonary congestion score
研究概览
简要总结
The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term.
详细描述
The point-of-care ultrasound was thought useful in the management of fluid in critically ill patients. At present, the role of the lung and inferior vena cava ultrasound is unclear in the management of decongestion of heart failure in kidney failure (KF) patients using prolonged hemodialysis. The investigators aim to explore the effect of pre-dialysis probing with the lung and inferior vena cava to guide fluid removal as compared with conventional protocols on the improvement of heart failure symptoms in patients with KF with heart failure under prolonged hemodialysis in the short-term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients meet the diagnostic criteria for end-stage renal disease;
- •indications that the patient may be experiencing signs and/or symptoms of heart failure, and based on the serum N-terminal pro-brain natriuretic peptide level of greater than 11,
- •patients may require prolonged intermittent renal replacement therapy due to volume overload;
- •patients ≥18 yo and ≤80 yo;
- •either the patient or a family member signs the informed consent;
- •patients will undergo at least two sessions of prolonged hemodialysis.
排除标准
- •history of malignancy or psychiatric disease;
- •patients with a history of congenital heart disease or hypertrophic cardiomyopathy;
- •coagulation abnormalities, intracranial, visceral or gastrointestinal bleeding in the past 3 months, or contraindications to heparin anticoagulation;
- •The duration of prolonged hemodialysis <8 hours;
- •Ultrasound unable to monitor the inferior vena cava, or can't access the date;
- •Patients with severe respiratory failure;
- •Patients with combined severe infections, such as patients with sepsis;
- •Presence of pre-dialysis hypotension: systolic blood pressure <90 mmHg;
- •other conditions deemed ineligible by physicians.
结局指标
主要结局
Improvement in pulmonary congestion score
时间窗: within 72 hours following randomization
Improvement in heart failure symptoms score
时间窗: within 72 hours following randomization
次要结局
- Total ultrafiltration volume(within 72 hours following randomization)
- The change of width of inferior vena cava(within 72 hours following randomization)
- Length of hospital stay(From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days)
- Fluid balance (total outflow - total inflow)(within 72 hours following randomization)
- Lung B-line reduction(within 72 hours following randomization)
- Incidence of hypotension during prolonged hemodialysis(within 72 hours following randomization)
- Mean ultrafiltration rate during prolonged hemodialysis(within 72 hours following randomization)
- Blood pressure variability during the prolonged hemodialysis(within 72 hours following randomization)
- In-hospital mortality(From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days)