Fluid Management in Sickle Cell Disease Vaso-occlusive Crisis: Restrictive Versus Liberal Strategies: A Randomized Controlled Trial (FLASC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 394
- 试验地点
- 2
- 主要终点
- Change in Pain intensity
研究概览
简要总结
Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications. Despite hydration being a cornerstone of VOC management, the optimal fluid strategy remains uncertain. This study evaluates restrictive versus liberal fluid management strategies in patients with acute VOC.
This multi-center, open-label, non-inferiority RCT will enroll patients with SCD presenting with acute VOC. Participants will be randomized to either a restrictive or liberal intravenous fluid management protocol. Primary outcome is pain score reduction. Secondary outcomes include time to pain resolution, ED length of stay, hospital admission rate, cumulative opioid dose, adverse events (incidence of fluid overload, pulmonary congestion), acute chest syndrome, incidence of acute kidney injury, revisit rates within 72 hours of ED discharge, need for intensive care or high-dependency unit admission, need for additional interventions, and 28 days overall mortality. Data will be analyzed using intention-to-treat principles.
We hypothesize that a restrictive fluid strategy will achieve non-inferior pain control compared to a liberal strategy, while minimizing fluid-related complications. This study will provide evidence to inform clinical guidelines for fluid management in SCD patients experiencing VOCs.
详细描述
This study is a prospective, non-inferiority, open-label, multicenter randomized-controlled trial (RCT) conducted in the emergency departments (EDs) of tertiary care hospitals in Saudi Arabia. The primary objective is to compare two fluid management strategies- restrictive (intervention) vs. liberal (control) in adult sickle cell disease (SCD) patients hospitalized for VOC. The study evaluates whether a restrictive fluid approach is non-inferior to a liberal strategy in terms of pain resolution, hospitalization duration, and other clinical outcomes.
Patients will be randomized upon ED admission, and their assigned fluid regimen will be administered within the first hour. Clinical teams will monitor outcomes throughout hospitalization or up to 28 days post-enrollment.
Study Population
- Recruitment Screening: All patients admitted to the ED with VOC will be screened for eligibility.
Consent Model: A priori informed written consent will be obtained from conscious, coherent patients or substitute decision-makers. 2. Inclusion Criteria Age >18 years with confirmed SCD diagnosis.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years old with a confirmed diagnosis of SCD.
- •Presenting with a VOC.
- •Willingness to participate and provide informed consent.
排除标准
- •Patient requiring specialized IVF management as per the treating physician discretion.
- •Patients with congestive heart failure, and /or acute or chronic symptomatic systolic heart failure
- •Patients with ESRD on chronic dialysis
- •Patients with signs of shock (low SBP <100 or MAP < 65) and signs of hypo perfusion
- •Known or suspected pregnancy
- •Previously enrolled in this trial within the last 30 days
- •Enrolled in another trial study that interfered with fluid management
- •Unable to obtain IV access.
研究组 & 干预措施
Liberal Approach Group
Patients will receive an IV bolus of 20 mL/kg of normal saline or lactated Ringer's over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements
干预措施: Sodium Chloride (NaCl) 0.9 % (Drug)
Restricted approach group
Patients in this arm will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered
干预措施: Sodium Chloride (NaCl) 0.9 % (Drug)
结局指标
主要结局
Change in Pain intensity
时间窗: Baseline (within 30 minutes post admission), 1 hour, then hourly until ED discharge or 24- 48- and 72-hours post-admission ( for admitted patients)
Measured using the Numeric Pain Rating Scale (NPRS)
次要结局
- Time to pain resolution(up to 4 hours)
- ED length of stay(at least 4 hours)
- Hospital admission rate(within 24 hours of ED admission)
- Cumulative Opioid Dose(up to 4 hours)
- Revisit Rates(within 72 hours post ED discharge)
- Overall Mortality(within 28 days post-enrollment)
- Adverse events(up to 7 days)
研究者
Mohammed Saeed Saad Alshahrani
Consultant, Emergency and Critical Care Departments
Imam Abdulrahman Bin Faisal University