Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-25 @ 2:11 PM
Study NCT ID:
NCT07188766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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.\n\nControl 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."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 394}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain intensity', 'timeFrame': 'Baseline (within 30 minutes post admission), 1 hour, then hourly until ED discharge or 24- and 48-hours post-admission ( for admitted patients)', 'description': 'Measured using the Numeric Pain Rating Scale (NPRS)'}], 'secondaryOutcomes': [{'measure': 'Time to pain resolution', 'timeFrame': 'up to 4 hours', 'description': 'NPRS score of ≤5'}, {'measure': 'ED length of stay', 'timeFrame': 'at least 4 hours', 'description': 'time elapsed from ED admission to ED discharge or admit to the wards'}, {'measure': 'Hospital admission rate', 'timeFrame': 'within 24 hours of ED admission', 'description': 'Proportion of participants requiring inpatient admission'}, {'measure': 'Cumulative Opioid Dose', 'timeFrame': 'up to 4 hours', 'description': 'Total opioid consumption during acute VOC episode'}, {'measure': 'Revisit Rates', 'timeFrame': 'within 72 hours post ED discharge', 'description': 'Percentage of patients who revisited the emergency department'}, {'measure': 'Overall Mortality', 'timeFrame': 'within 28 days post-enrollment', 'description': 'number of patients who died'}, {'measure': 'Adverse events', 'timeFrame': 'up to 7 days', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sickle cell disease', 'sickle cell crisis', 'intravenous fluid', 'emergency department'], 'conditions': ['SCD', 'Vaso Occlussive Crisis']}, 'referencesModule': {'references': [{'pmid': '28853040', 'type': 'BACKGROUND', 'citation': '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': '31933113', 'type': 'BACKGROUND', 'citation': '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': '25764071', 'type': 'BACKGROUND', 'citation': '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': '32559294', 'type': 'BACKGROUND', 'citation': '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': '6999348', 'type': 'BACKGROUND', 'citation': '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': '37331373', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nWe 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.', 'detailedDescription': '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.\n\nPatients 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.\n\nStudy Population\n\n1. Recruitment Screening: All patients admitted to the ED with VOC will be screened for eligibility.\n\n Consent Model: A priori informed written consent will be obtained from conscious, coherent patients or substitute decision-makers.\n2. Inclusion Criteria Age \\>18 years with confirmed SCD diagnosis.\n\n Presenting with VOC requiring hospitalization.\n\n Willingness to participate and provide informed consent.\n3. Exclusion Criteria Requiring specialized IVF management per physician discretion.\n\nCardiac/Renal Conditions:\n\nCongestive heart failure (CHF) or symptomatic systolic heart failure.\n\nChronic kidney disease (CKD), acute kidney injury (AKI), or renal transplantation.\n\nHemodynamic Instability:\n\nShock (SBP \\<100 mmHg or MAP \\<65) with hypoperfusion signs.\n\nOther Exclusions:\n\nKnown/suspected pregnancy.\n\nPrior enrollment in this trial within the last 30 days.\n\nConcurrent enrollment in another trial affecting fluid management.\n\nInability to obtain IV access.\n\nTrial Intervention\n\n1. Screening \\& Randomization Screening occurs upon ED admission; evaluations must precede randomization.\n\n A screening log will track eligible vs. randomized patients.\n2. Informed Consent A-priori consent model used due to the conscious-coherent state of most SCD patients in VOC.\n\n Efforts will be made to obtain consent immediately from the patient or surrogate.\n3. Intervention Arms A. Intervention (Restrictive)Keep-vein-open (KVO) rate only (minimal fluids to maintain IV patency). No additional IV fluids administered.\n\nB. Control (Liberal) 20 mL/kg IV bolus (NS or LR over 1 hour) + maintenance fluids (1.5-2 mL/kg/day).\n\nInitiation: Both regimens start within 1 hour of ED admission and continue until ED discharge.\n\nHospitalized Patients:\n\nPain scores (NPRS) recorded at 24 \\& 48 hours. Total fluid intake documented at hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients \\>18 years old with a confirmed diagnosis of SCD.\n2. Presenting with a VOC.\n3. Willingness to participate and provide informed consent.\n\nExclusion Criteria:\n\n1. Patient requiring specialized IVF management as per the treating physician discretion.\n2. Patients with congestive heart failure, and /or acute or chronic symptomatic systolic heart failure\n3. Patients with a history of chronic kidney disease, acute kidney injury or renal transplantation\n4. Patients with signs of shock (low SBP \\<100 or MAP \\< 65) and signs of hypo perfusion\n5. Known or suspected pregnancy\n6. Previously enrolled in this trial within the last 30 days\n7. Enrolled in another trial study that interfered with fluid management\n8. Unable to obtain IV access.'}, 'identificationModule': {'nctId': 'NCT07188766', 'acronym': 'FLASC', 'briefTitle': 'Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis', 'organization': {'class': 'OTHER', 'fullName': 'Imam Abdulrahman Bin Faisal University'}, 'officialTitle': 'Fluid Management in Sickle Cell Disease Vaso-occlusive Crisis: Restrictive Versus Liberal Strategies: A Randomized Controlled Trial (FLASC Trial)', 'orgStudyIdInfo': {'id': '2025-01-0451'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Restricted approach group', 'description': 'Patients in this arm will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered', 'interventionNames': ['Drug: Sodium Chloride (NaCl) 0.9 %']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal Approach Group', 'description': "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", 'interventionNames': ['Drug: Sodium Chloride (NaCl) 0.9 %']}], 'interventions': [{'name': 'Sodium Chloride (NaCl) 0.9 %', 'type': 'DRUG', 'otherNames': ['Restricted'], 'description': 'Keep vein open rate', 'armGroupLabels': ['Restricted approach group']}, {'name': 'Sodium Chloride (NaCl) 0.9 %', 'type': 'DRUG', 'otherNames': ['Liberal'], 'description': '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', 'armGroupLabels': ['Liberal Approach Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohammed S Alshahrani, MD', 'role': 'CONTACT', 'email': 'msshahrani@iau.edu.sa', 'phone': '+966556966663'}, {'name': 'Laila Perlas Asonto, RN', 'role': 'CONTACT', 'email': 'lasonto@iau.edu.sa'}], 'overallOfficials': [{'name': 'Mohammed S Alshahrani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Fahd Hospital of the University- Imam Abdulrahman Bin Faisal University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': '1. Demographics: Age, sex, and other baseline characteristics.\n2. Outcome Measures: primary and secondary outcomes of the trial.\n3. Adverse Events: Data on side effects or other adverse events participants experienced during the trial.\n4. Treatment Allocations: Information on which participants were assigned to each treatment group.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Emergency and Critical Care Departments', 'investigatorFullName': 'Mohammed Saeed Saad Alshahrani', 'investigatorAffiliation': 'Imam Abdulrahman Bin Faisal University'}}}}