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

NCT07188766 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2026-03-18

No results posted yet for this study

Summary

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.

Conditions

  • SCD
  • Vaso Occlussive Crisis

Interventions

DRUG

Sodium Chloride (NaCl) 0.9 %

Keep vein open rate

DRUG

Sodium Chloride (NaCl) 0.9 %

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

Sponsors & Collaborators

  • Imam Abdulrahman Bin Faisal University

    lead OTHER

Principal Investigators

  • Mohammed S Alshahrani, MD · King Fahd Hospital of the University- Imam Abdulrahman Bin Faisal University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-05
Primary Completion
2028-08-31
Completion
2028-10-31

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188766 on ClinicalTrials.gov