Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis
About this study
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.
- Condition
- SCD, Vaso Occlussive Crisis
- Tested
- Sodium Chloride (NaCl) 0.9 %, Sodium Chloride (NaCl) 0.9 %
- Sponsor
- Imam Abdulrahman Bin Faisal University
Who can join
- Age
- 18 to 60 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Maximum age: 60 years
- Study condition: SCD, Vaso Occlussive Crisis
- Patients \>18 years old with a confirmed diagnosis of SCD.
- Presenting with a VOC.
- NPRS \>5
- Willingness to participate and provide informed consent.
Exclusion 8
- 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.
Where
2 sites, 2 recruiting
King Fahd Hospital of the University
Dammam, Eastern Province, Saudi Arabia
King Saud University Medical City
Riyadh, Saudi Arabia
Contact
-
Mohammed S Alshahrani, MD
+966556966663 msshahrani@iau.edu.sa
-
Laila Perlas Asonto, RN
Potential match only. Final eligibility is determined by the study team.