Peripheral Perfusion Targeted Fluid Management in Critically Ill Patients: a Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fluid balance during Intensive Care Unit stay
研究概览
简要总结
- Impaired peripheral perfusion is related to worse outcome in critically ill patients. Although this is known, these parameters have never been used as target for hemodynamic therapy.
- We hypothesize that targeting of fluid administration on parameters of peripheral perfusion might prevent excessive fluid administration, leading to less formation of tissue edema, less respiratory dysfunction and shorter duration of mechanical ventilation in critically ill patients.
详细描述
Rationale: Currently, fluid administration of critically ill patients is aimed at optimizing conventional hemodynamic parameters such as stroke volume and cardiac output. Fluid is infused repeatedly until patients become "non-responsive", i.e. cardiac output does not increase anymore. However, the ultimate goal of hemodynamic therapy should be to improve peripheral (i.e. tissue) perfusion. Recently we have shown that 1) increasing stroke volume does not always have an effect on peripheral perfusion and 2) that peripheral perfusion is not impaired when stroke volume can still be increased with fluid infusion. Furthermore, repeated administration of fluid in order to reach a maximum cardiac output can lead to an enormous accumulation of fluid in the patient. This leads to formation of lung edema and respiratory dysfunction and is associated with prolonged mechanical ventilation and ICU-stay. Recently, techniques have been developed which allow bedside assessment of peripheral perfusion. Although impaired peripheral perfusion was related to worse outcome, these parameters have never been used as target for hemodynamic therapy.
Objective: To study whether peripheral perfusion targeted fluid management (PPTFM) leads to less fluid administration, improved respiratory function and shorter mechanical ventilation.
Study design: The study is a pilot study and is designed as a randomized controlled trial. The study will be conducted as a single-center study at the Intensive Care of the Erasmus Medical Center.
Study population: We aim to include 40 adult patients who are admitted to the Intensive Care with hemodynamic instability (defined as mean arterial pressure < 65 mmHg and an arterial lactate concentration > 3.0 mmol/l) due to severe sepsis and septic shock.
Intervention: In the intervention group fluid management is targeted on peripheral perfusion parameters while in the control group fluid is administered in order to optimize cardiac output.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (>18 years) admitted to the intensive care with 1) hemodynamic instability due to severe sepsis, and 2) a mean arterial pressure < 65 mmHg and 3) an arterial lactate concentration > 3.0 mmol/L will be considered for participation
排除标准
- •moribund.
- •severe coagulation disorder (contraindication for central venous catheter placement).
- •severe peripheral vascular disease (interfering with peripheral perfusion measurement).
研究组 & 干预措施
Control
The fluid management algorithm of the control group is based on the standard care procedure of our ICU as recommended in guidelines: the patient's fluid status is assessed by performing a fluid challenge with a bolus of 250 ml colloids. When the patients is fluid responsive (i.e. showing an increase in stroke volume > 10% ) he will receive an additional bolus of 250 ml of colloids. After each fluid challenge, patients will be revaluated for fluid responsiveness to access need of further fluid administration.
PPTFM
The fluid management algorithm of the intervention group uses identical therapy (i.e. fluids) yet targeted at different endpoints (i.e. peripheral perfusion parameters). After evaluation of peripheral perfusion, only patients with a "bad peripheral perfusion" (i.e. 3 out of 4 criteria considered as bad) will receive a fluid challenge, the same way as in the standard care procedure (i.e. bolus of 250 ml of fluid). After each fluid challenge, patients will be re-evaluated for peripheral perfusion to access further need in fluid challenges. To ensure that no hypovolemia will occur in the intervention group, fluid will be administered irrespectively of peripheral perfusion parameters, if cardiac index falls below a value of 2,5 L/min/m2.
干预措施: PPTFM (Other)
结局指标
主要结局
Fluid balance during Intensive Care Unit stay
时间窗: untill 72 hours after admission
Total and daily fuid balance for a maximal time period of 72 hours
次要结局
- CRT (Capillary refill time)(Within 72 hours after admission)
- Systemic hemodynamic variables(Untill 72 hours after admission to the ICU)
- Respiratory function(Untill 72 hours after admission to the ICU)
- PFI (Peripheral Flow Index)(Untill 72 hours after ICU admission)
- Tskindiff (Forearm-to-Fingertip temperature skin difference)(Untill 72 hours after ICU admission)
- StO2 (Peripheral tissue oxygenation)(Untill 72 hours after ICU admission)
研究者
ME van Genderen
Drs
Erasmus Medical Center