Optimal Timing of Renal Replacement Therapy in Hypervolemic Cardiogenic Shock
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
CAPITAL OFFLOAD-SHOCK will aim to answer if early use of renal replacement therapy, like dialysis, in patients with reduced body fluids causing the heart to be unable to pump enough blood through the body reduces in-hospital death when compared to the current standard of care. The current standard of care is to wait until renal replacement therapy is clinically necessary.
详细描述
The trial will evaluate the in-hospital mortality between starting renal replacement therapy (RRT) immediately upon confirmation of eligibility and consent and using standard medical therapy without RRT unless one of the following occurs:
- clinical volume overload refractory to diuresis with high-dose intravenous furosemide plus either thiazide-like diuretic and/or acetazolamide, resulting in pulmonary edema, necessitation ventilation with F1O2 > 50%
- hyperkalemia with serum potassium >6mmol/L
- Severe metabolic acidosis with pH <7.2 and bicarb <12 mmol/L thought to be due to renal insufficiency.
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
- None
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 patients >/= 18 years of age admitted to an intensive care unit
- •Diagnosed clinically with Society for Cardiovascular Angiography and Interventions (SCAI) Class C or D cardiogenic shock
- •Clinical or hemodynamic evidence of volume overload
排除标准
- •* Patients whose care plan, as determined by the treating clinical team, will not include renal replacement therapy
- •* Decision has already been made by the treating clinical team to initiate renal replacement therapy
- •* Hyperkalemia with serum potassium \>/= 6mmol/L at the time of screening
- •* Severe metabolic acidosis with serum bicarbonate \/= 40 mmol/L at the time of screening
- •* Acute intoxication necessitating use of renal replacement therapy
- •* Recent renal replacement therapy (within 30 days)
- •* Known end-stage renal disease (defined as an estimated glomerular filtration rate \<15 ml/min/1.73m2
- •* presentation with out-of-hospital cardiac arrest
研究组 & 干预措施
Immediate Renal Replacement Therapy
Participants receive renal replacement therapy within 2-6 hours of randomization.
干预措施: Immediate renal replacement therapy (Drug)
Standard Medical Treatment
Participants will receive the standard of care medical therapy with discouragement of renal replacement therapy unless medically necessary.
结局指标
主要结局
All cause mortality
时间窗: Baseline to 90 days
Occurrences of death from any cause
Increased Serum Lactate
时间窗: Randomization to 24 hours post randomization.
Serum lactate greater than 3.5mmol/L between 6 and 24hours after randomization
Mechanical Circulatory Support
时间窗: Baseline to Hospital Discharge - expected up to 90 days
New need for, or replacement of, a mechanical circulatory support device.
Resuscitated cardiac arrest
时间窗: Baseline to Hospital Discharge - expected up to 90 days
Occurrences of resuscitated cardiac arrest
次要结局
- Continued renal replacement therapy(Baseline to Hospital Discharge - expected up to 90 days)
- Length of hospital stay(Baseline to Hospital Discharge - expected up to 90 days)
- Length of intensive care unit stay(Baseline to Hospital Discharge - expected up to 90 days)
- Major bleeding events(Baseline to Hospital Discharge - expected up to 90 days)
- All-cause mortality(Baseline to Hospital Discharge - expected up to 90 days)
- Ventilator free days(Baseline to 90 days)
- Re-hospitalization(Baseline to 90 days)
- Renal Replacement Therapy dependence(Baseline to 90 days)
- Days out of hospital(Baseline to 90 days)
- Quality of Life Evaluation(Baseline to 90 days)