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

NCT07188766 | Recruiting DMC

• 1 other identifier: 2025-01-0451
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

sickle cell disease; sickle cell crisis; intravenous fluid; emergency department

Outcome Measures

Primary Outcomes (1)

• Change in Pain intensity

  Measured using the Numeric Pain Rating Scale (NPRS)

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

Secondary Outcomes (7)

• Time to pain resolution

  up to 4 hours

• ED length of stay

  at least 4 hours

• Hospital admission rate

  within 24 hours of ED admission

• Cumulative Opioid Dose

  up to 4 hours

• Revisit Rates

  within 72 hours post ED discharge

Study Arms (2)

Restricted approach group

EXPERIMENTAL

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 %

Liberal Approach Group

ACTIVE COMPARATOR

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 %

Interventions

Sodium Chloride (NaCl) 0.9 % DRUG

Keep vein open rate

Also known as: Restricted

Restricted approach group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients \>18 years old with a confirmed diagnosis of SCD.
• Presenting with a VOC.
• NPRS \>5
• Willingness to participate and provide informed consent.

You may not qualify if:

• Patient requiring specialized IVF management as per the treating physician discretion.
• Patients with congestive heart failure, and /or acute or chronic symptomatic systolic heart failure
• Patients with ESRD on chronic dialysis
• Patients with signs of shock (low SBP \<100 or MAP \< 65) and signs of hypo perfusion
• Known or suspected pregnancy
• Previously enrolled in this trial within the last 30 days
• Enrolled in another trial study that interfered with fluid management
• Unable to obtain IV access.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (2)

King Fahd Hospital of the University

Dammam, Eastern Province, 31952, Saudi Arabia

RECRUITING

King Saud University Medical City

Riyadh, Saudi Arabia

RECRUITING

Related Publications (6)

• Puri L, Nottage KA, Hankins JS, Anghelescu DL. State of the Art Management of Acute Vaso-occlusive Pain in Sickle Cell Disease. Paediatr Drugs. 2018 Feb;20(1):29-42. doi: 10.1007/s40272-017-0263-z.

  PMID: 28853040 BACKGROUND

• Rizio AA, Bhor M, Lin X, McCausland KL, White MK, Paulose J, Nandal S, Halloway RI, Bronte-Hall L. The relationship between frequency and severity of vaso-occlusive crises and health-related quality of life and work productivity in adults with sickle cell disease. Qual Life Res. 2020 Jun;29(6):1533-1547. doi: 10.1007/s11136-019-02412-5. Epub 2020 Jan 13.

  PMID: 31933113 BACKGROUND

• Okomo U, Meremikwu MM. Fluid replacement therapy for acute episodes of pain in people with sickle cell disease. Cochrane Database Syst Rev. 2015 Mar 12;(3):CD005406. doi: 10.1002/14651858.CD005406.pub4.

  PMID: 25764071 BACKGROUND

• Brandow AM, Carroll CP, Creary S, Edwards-Elliott R, Glassberg J, Hurley RW, Kutlar A, Seisa M, Stinson J, Strouse JJ, Yusuf F, Zempsky W, Lang E. American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Blood Adv. 2020 Jun 23;4(12):2656-2701. doi: 10.1182/bloodadvances.2020001851.

  PMID: 32559294 BACKGROUND

• Rosa RM, Bierer BE, Thomas R, Stoff JS, Kruskall M, Robinson S, Bunn HF, Epstein FH. A study of induced hyponatremia in the prevention and treatment of sickle-cell crisis. N Engl J Med. 1980 Nov 13;303(20):1138-43. doi: 10.1056/NEJM198011133032002.

  PMID: 6999348 BACKGROUND

• GBD 2021 Sickle Cell Disease Collaborators. Global, regional, and national prevalence and mortality burden of sickle cell disease, 2000-2021: a systematic analysis from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Aug;10(8):e585-e599. doi: 10.1016/S2352-3026(23)00118-7. Epub 2023 Jun 15.

  PMID: 37331373 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Emergencies

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mohammed S Alshahrani, MD

  King Fahd Hospital of the University- Imam Abdulrahman Bin Faisal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed S Alshahrani, MD

CONTACT

+966556966663; msshahrani@iau.edu.sa

Laila Perlas Asonto, RN

CONTACT

lasonto@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Emergency and Critical Care Departments

Model Details: This is a prospective, non-inferiority, open label multicenter randomized controlled trial. Patients on Intervention Group (Restricted approach group) will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered. Control Group (Liberal Approach Group) 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.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 23, 2025
• Study Start: October 5, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

SA (2)