Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Cumulative Fluid Administered
研究概览
简要总结
The purpose of the study is to determine if a protocol that assesses patients' daily fluid intake and output can decrease the overall amount of fluid patients receive during the first five days in the ICU. The study will also determine if decreasing overall fluids can decrease adverse events associated with mechanical ventilation, such as ventilator-associated pneumonias.
The protocol will include daily ultrasounds and blood draws to evaluate fluid balance. Ultrasound will be used to measure changes in the diameter of the inferior vena cava with respiration.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient with septic shock as the primary cause of hypotension
- •Requiring vasopressors for 12 hours after adequate fluid resuscitation and at the time of enrollment
排除标准
- •Patients with a history of end-stage renal disease requiring outpatient dialysis
- •Patients whose goals of care are consistent with comfort measures only
- •Pregnant patients
研究组 & 干预措施
Fluid minimization group
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. A fluid challenge in the form of a leg raise or infusion of 250 mL of crystalloid over 5 minutes will then be performed and the parameters repeated. The patient will be judged to be fluid responsive or nonresponsive based on the changes in the parameters. Fluid nonresponsive patients will receive the intervention of the fluid minimization protocol by concentrating continuous infusions, discontinuing maintenance fluids, and minimizing carrier fluids. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
干预措施: Fluid minimization protocol (Other)
Fluid minimization group
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. A fluid challenge in the form of a leg raise or infusion of 250 mL of crystalloid over 5 minutes will then be performed and the parameters repeated. The patient will be judged to be fluid responsive or nonresponsive based on the changes in the parameters. Fluid nonresponsive patients will receive the intervention of the fluid minimization protocol by concentrating continuous infusions, discontinuing maintenance fluids, and minimizing carrier fluids. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
干预措施: Ultrasound (Device)
Usual care group
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.
结局指标
主要结局
Cumulative Fluid Administered
时间窗: Day 5
Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5
Net Fluid Balance
时间窗: Day 5
Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5
Cumulative Fluid Administered
时间窗: Day 3
Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3
Net Fluid Balance
时间窗: Day 3
Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3
次要结局
- Rate of Renal Replacement Therapy(ICU stay, median of 10 days)
- Ventilator Days(Hospital stay, median of 16 days)
- Mortality(ICU stay, median of 10 days)
- Mortality(Hospital stay, median of 16 days)