An interventional study of Sodium Chloride (NaCl) 0.9 % and Sodium Chloride (NaCl) 0.9 % in SCD and Vaso Occlussive Crisis, sponsored by Imam Abdulrahman Bin Faisal University. Recruiting at 2 sites in Saudi Arabia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Imam Abdulrahman Bin Faisal University · Not applicable, Interventional, and Treatment
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.
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
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.
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.
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
Screening \& Randomization Screening occurs upon ED admission; evaluations must precede randomization.
A screening log will track eligible vs. randomized patients.
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.
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.
Exclusion Criteria:
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
Also known as: Restricted
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
Also known as: Liberal
Change in Pain intensity
Measured using the Numeric Pain Rating Scale (NPRS)
Time frame: Baseline (within 30 minutes post admission), 1 hour, then hourly until ED discharge or 24- 48- and 72-hours post-admission ( for admitted patients)
Time to pain resolution
NPRS score of ≤5
Time frame: up to 4 hours
ED length of stay
time elapsed from ED admission to ED discharge or admit to the wards
Time frame: at least 4 hours
Hospital admission rate
Proportion of participants requiring inpatient admission
Time frame: within 24 hours of ED admission
Cumulative Opioid Dose
Total opioid consumption during acute VOC episode
Time frame: up to 4 hours
Revisit Rates
Percentage of patients who revisited the emergency department
Time frame: within 72 hours post ED discharge
Overall Mortality
number of patients who died
Time frame: within 28 days post-enrollment
Adverse events
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)
Time frame: up to 7 days
Plan to share: Yes — 1. Demographics: Age, sex, and other baseline characteristics. 2. Outcome Measures: primary and secondary outcomes of the trial. 3. Adverse Events: Data on side effects or other adverse events participants experienced during the trial. 4. Treatment Allocations: Information on which participants were assigned to each treatment group.
Supporting information: Study protocol, Sap, Icf, Csr
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Imam Abdulrahman Bin Faisal University