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Clinical trial Recruiting at 5 sites Interventional Ages 18 to 60

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

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

Run by Imam Abdulrahman Bin Faisal University · NCT07188766 · Data updated 2026-11-12

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

More Subjective Cognitive Decline (SCD) trials

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment394 (estimated)
SponsorImam Abdulrahman Bin Faisal University
Academic / other
Locations5 sites (Dammam, Eastern Province and 4 other locations)
StatusRecruiting
StartedOctober 5, 2025
Main results expectedAugust 2028
Study endsOctober 2028
Registry record updatedNovember 10, 2026
Trial IDNCT07188766 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • King Fahd Hospital of the University
    Dammam, Eastern Province, Saudi Arabia     Recruiting
  • John Hopkins Aramco Healthcare
    Dhahran, Saudi Arabia     Recruiting
  • King Fahad Military Medical Complex
    Dhahran, Saudi Arabia     Recruiting
  • Jubail General Hospital
    Jubail, 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
  • Email: msshahrani@iau.edu.sa
  • Phone: +966556966663

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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SCD 5Imam Abdulrahman Bin Faisal University 4
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.