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

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 primary objective is to compare two fluid management strategies- restrictive (intervention) vs. liberal (control) in adult sickle cell disease (SCD) patients hospitalized for VOC. The study evaluates whether a restrictive fluid approach is non-inferior to a liberal strategy in terms of pain resolution, hospitalization duration, and other clinical outcomes.

Patients will be randomized upon ED admission, and their assigned fluid regimen will be administered within the first hour. Clinical teams will monitor outcomes throughout hospitalization or up to 28 days post-enrollment.

Study Population

1. Recruitment Screening: All patients admitted to the ED with VOC will be screened for eligibility.

Consent Model: A priori informed written consent will be obtained from conscious, coherent patients or substitute decision-makers.
2. Inclusion Criteria Age \>18 years with confirmed SCD diagnosis.

Presenting with VOC requiring hospitalization.

Numeric Pain Rating Scale (NPRS) \>5

Willingness to participate and provide informed consent.
3. Exclusion Criteria Requiring specialized IVF management per the physician's discretion.

Cardiac/Renal Conditions:

Congestive heart failure (CHF) or symptomatic systolic heart failure.

Patients with ESRD on chronic dialysis.

Hemodynamic Instability:

Shock (SBP \<100 mmHg or MAP \<65) with hypoperfusion signs.

Other Exclusions:

Known/suspected pregnancy.

Prior enrollment in this trial within the last 30 days.

Concurrent enrollment in another trial affecting fluid management.

Inability to obtain IV access.

Trial Intervention

1. Screening \& Randomization Screening occurs upon ED admission; evaluations must precede randomization.

A screening log will track eligible vs. randomized patients.
2. Informed Consent An a priori consent model is used due to the conscious-coherent state of most SCD patients in VOC.

Efforts will be made to obtain consent immediately from the patient or surrogate.
3. Intervention Arms A. Intervention (Restrictive)Keep-vein-open (KVO) rate only (minimal fluids to maintain IV patency). No additional IV fluids administered.

B. Control (Liberal) 20 mL/kg IV bolus (NS or LR over 1 hour) + maintenance fluids (1.5-2 mL/kg/day).

Initiation: Both regimens starts within 1 hour of ED admission and continue until ED discharge.

Hospitalized Patients:

Pain scores (NPRS) recorded at 24, 48, and 72 hours. Total fluid intake documented at hospital discharge.

Patients in this arm will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered

Drug: Sodium Chloride (NaCl) 0.9 %

Patients will receive an IV bolus of 20 mL/kg of normal saline or lactated Ringer's over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements

Drug: Sodium Chloride (NaCl) 0.9 %

Keep vein open rate

IV bolus of 20 mL/kg of normal saline over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements

Plazo: Baseline (within 30 minutes post admission), 1 hour, then hourly until ED discharge or 24- 48- and 72-hours post-admission ( for admitted patients)

Measured using the Numeric Pain Rating Scale (NPRS)

Plazo: up to 4 hours

NPRS score of ≤5

Plazo: at least 4 hours

time elapsed from ED admission to ED discharge or admit to the wards

Plazo: within 24 hours of ED admission

Proportion of participants requiring inpatient admission

Plazo: up to 4 hours

Total opioid consumption during acute VOC episode

Plazo: within 72 hours post ED discharge

Percentage of patients who revisited the emergency department

Plazo: within 28 days post-enrollment

number of patients who died

Plazo: up to 7 days

total number of patients who encountered allergic reactions, respiratory distress, pulmonary edema, and acute chest syndrome, development of tachypnea, hypoxia, cough, crackles on auscultation, elevated BP, need for respiratory support, heart failure (worsening of tachycardia, hepatomegaly, peripheral edema, and allergic reactions (urticaria, angioedema, hypotension, wheezing)

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