Status:
NOT_YET_RECRUITING
Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis
Lead Sponsor:
Imam Abdulrahman Bin Faisal University
Conditions:
SCD
Vaso Occlussive Crisis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 V...
Detailed Description
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 pri...
Eligibility Criteria
Inclusion
- Patients \>18 years old with a confirmed diagnosis of SCD.
- Presenting with a VOC.
- Willingness to participate and provide informed consent.
Exclusion
- 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 a history of chronic kidney disease, acute kidney injury or renal transplantation
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT07188766
Start Date
October 1 2025
End Date
October 1 2026
Last Update
September 23 2025
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