Liberal versus restricted IV fluids for adults with sickle cell pain crises

Fluid Management in Sickle Cell Disease Vaso-occlusive Crisis: Restrictive Versus Liberal Strategies: A Randomized Controlled Trial (FLASC Trial)

This will test whether giving less IV fluid works as well as more IV fluid for adults with sickle cell vaso‑occlusive pain crises.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 394 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Imam Abdulrahman Bin Faisal University (Academic / other)
• Locations: 2 sites (Dammam, Eastern Province and 1 other locations)
• Trial ID: NCT07188766 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, non-inferiority randomized trial in Saudi Arabian emergency departments randomizes adults with sickle cell disease and acute vaso-occlusive crises to restrictive or liberal IV fluid regimens delivered within the first hour of ED admission. The primary outcome is reduction in pain score, and secondary outcomes include time to pain resolution, ED length of stay, hospital admission rate, cumulative opioid use, and adverse events such as fluid overload, acute chest syndrome, and acute kidney injury. Patients are followed during hospitalization and up to 28 days after enrollment, with key exclusions for congestive heart failure, end-stage renal disease on dialysis, shock, and pregnancy. Clinical teams provide standard analgesia alongside the assigned fluid protocol and collect outcome measures throughout the acute care episode.

Who should consider this trial

Good fit: Adults (≥18 years) with confirmed sickle cell disease presenting to participating EDs with a vaso-occlusive crisis and a pain score over 5 who can provide informed consent and do not have cardiac, renal, or pregnancy contraindications.

Not a fit: Patients with congestive heart failure, end-stage renal disease on dialysis, signs of shock, known or suspected pregnancy, or who require specialized IV fluid management are unlikely to benefit from the restrictive protocol tested here.

Why it matters

Potential benefit: If successful, the restrictive approach could allow patients to receive less IV fluid without worse pain control, reducing fluid-related complications and potentially shortening hospital stays.

How similar studies have performed: Direct randomized comparisons of liberal versus restrictive IV fluids in VOCs are limited and most prior guidance is observational or expert-based, so this RCT approach is relatively novel.

Eligibility criteria

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.

Where this trial is running

Dammam, Eastern Province and 1 other locations

• King Fahd Hospital of the University — Dammam, Eastern Province, Saudi Arabia (Recruiting)
• King Saud University Medical City — Riyadh, Saudi Arabia (Recruiting)

Study contacts

• Principal investigator: Mohammed S Alshahrani, MD — King Fahd Hospital of the University- Imam Abdulrahman Bin Faisal University
• Study coordinator: Mohammed S Alshahrani, MD

Conditions SCD; Vaso Occlussive Crisis; sickle cell disease; sickle cell crisis; intravenous fluid; emergency department