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Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis

RecruitingNAAges 18 Years - 60 YearsAllImam Abdulrahman Bin Faisal University
NCT07188766 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients \>18 years old with a confirmed diagnosis of SCD. 2. Presenting with a VOC. 3. NPRS \>5 4. Willingness to participate and provide informed consent. Exclusion Criteria: 1. Patient requiring specialized IVF management as per the treating physician discretion. 2. Patients with congestive heart failure, and /or acute or chronic symptomatic systolic heart failure 3. Patients with ESRD on chronic dialysis 4. Patients with signs of shock (low SBP \<100 or MAP \< 65) and signs of hypo perfusion 5. Known or suspected pregnancy 6. Previously enrolled in this trial within the last 30 days 7. Enrolled in another trial study that interfered with fluid management 8. Unable to obtain IV access.
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What it tests

  • Sodium Chloride (NaCl) 0.9 %
  • Sodium Chloride (NaCl) 0.9 %
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Where

2 sites
King Fahd Hospital of the University
Dammam, Saudi Arabia
King Saud University Medical City
Riyadh, Saudi Arabia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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