Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-04 @ 12:47 AM
Study NCT ID:
NCT02316366
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2014-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Use of Warmed Saline in Vaso-occlusive Episodes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reneepetagae@gmail.com', 'phone': '2037136871', 'title': 'Dr. Renee Quarrie, fellow', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Warm Fluid', 'description': 'Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer\n\nAstoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Room Temperature Fluid', 'description': 'Patients receive intravenous saline at room temperature (22-24 degrees Celsius)', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Hospital Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Warm Fluid', 'description': 'Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer\n\nAstoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius'}, {'id': 'OG001', 'title': 'Room Temperature Fluid', 'description': 'Patients receive intravenous saline at room temperature (22-24 degrees Celsius)'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '78'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 hours', 'description': 'After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Warm Fluid', 'description': 'Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer\n\nAstoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius'}, {'id': 'OG001', 'title': 'Room Temperature Fluid', 'description': 'Patients receive intravenous saline at room temperature (22-24 degrees Celsius)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': "During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided. The difference between the pain score upon arrival and at discharge was assessed. Minimum value 1, maximum value 10 (most pain)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Disposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Warm Fluid', 'description': 'Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer\n\nAstoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius'}, {'id': 'OG001', 'title': 'Room Temperature Fluid', 'description': 'Patients receive intravenous saline at room temperature (22-24 degrees Celsius)'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000', 'lowerLimit': '140', 'upperLimit': '175'}, {'value': '155', 'groupId': 'OG001', 'lowerLimit': '135', 'upperLimit': '175'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'The amount of time spent in the ED was recorded for each patient', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Amount of Narcotic Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Warm Fluid', 'description': 'Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer\n\nAstoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius'}, {'id': 'OG001', 'title': 'Room Temperature Fluid', 'description': 'Patients receive intravenous saline at room temperature (22-24 degrees Celsius)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.39'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.38'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient', 'unitOfMeasure': 'mg/kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Global Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Warm Fluid', 'description': 'Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer\n\nAstoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius'}, {'id': 'OG001', 'title': 'Room Temperature Fluid', 'description': 'Patients receive intravenous saline at room temperature (22-24 degrees Celsius)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 hours', 'description': 'Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay. Question 2 of the survey addressed comfort by asking: "On a scale of 1 to 5, how do you think the fluid made you feel?" (1 is worse and 5 is better).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Warm Fluid', 'description': 'Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer\n\nAstoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius'}, {'id': 'FG001', 'title': 'Room Temperature Fluid', 'description': 'Patients receive intravenous saline at room temperature (22-24 degrees Celsius)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Warm Fluid', 'description': 'Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer\n\nAstoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius'}, {'id': 'BG001', 'title': 'Room Temperature Fluid', 'description': 'Patients receive intravenous saline at room temperature (22-24 degrees Celsius)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '13.6', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '14', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2014-12-10', 'resultsFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2014-12-11', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-31', 'studyFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Hospital Admission', 'timeFrame': '4 hours', 'description': 'After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.'}], 'secondaryOutcomes': [{'measure': 'Difference in Pain Score', 'timeFrame': '4 hours', 'description': "During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided. The difference between the pain score upon arrival and at discharge was assessed. Minimum value 1, maximum value 10 (most pain)"}, {'measure': 'Time to Disposition', 'timeFrame': '4 hours', 'description': 'The amount of time spent in the ED was recorded for each patient'}, {'measure': 'Amount of Narcotic Administered', 'timeFrame': '4 hours', 'description': 'The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient'}, {'measure': 'Global Comfort', 'timeFrame': '4 hours', 'description': 'Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay. Question 2 of the survey addressed comfort by asking: "On a scale of 1 to 5, how do you think the fluid made you feel?" (1 is worse and 5 is better).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease', 'Sickle Cell Crisis']}, 'referencesModule': {'references': [{'pmid': '21584938', 'type': 'BACKGROUND', 'citation': 'Raphael JL, Mei M, Mueller BU, Giordano T. High resource hospitalizations among children with vaso-occlusive crises in sickle cell disease. Pediatr Blood Cancer. 2012 Apr;58(4):584-90. doi: 10.1002/pbc.23181. Epub 2011 May 16.'}, {'pmid': '20530056', 'type': 'BACKGROUND', 'citation': 'Mousa SA, Al Momen A, Al Sayegh F, Al Jaouni S, Nasrullah Z, Al Saeed H, Alabdullatif A, Al Sayegh M, Al Zahrani H, Hegazi M, Al Mohamadi A, Alsulaiman A, Omer A, Al Kindi S, Tarawa A, Al Othman F, Qari M. Management of painful vaso-occlusive crisis of sickle-cell anemia: consensus opinion. Clin Appl Thromb Hemost. 2010 Aug;16(4):365-76. doi: 10.1177/1076029609352661. Epub 2010 Jun 7.'}, {'pmid': '18300322', 'type': 'BACKGROUND', 'citation': 'Raphael JL, Kamdar A, Wang T, Liu H, Mahoney DH, Mueller BU. Day hospital versus inpatient management of uncomplicated vaso-occlusive crises in children with sickle cell disease. Pediatr Blood Cancer. 2008 Sep;51(3):398-401. doi: 10.1002/pbc.21537.'}, {'pmid': '18383165', 'type': 'BACKGROUND', 'citation': 'Raphael JL, Kamdar A, Beavers MB, Mahoney DH, Mueller BU. Treatment of uncomplicated vaso-occlusive crises in children with sickle cell disease in a day hospital. Pediatr Blood Cancer. 2008 Jul;51(1):82-5. doi: 10.1002/pbc.21483.'}, {'pmid': '19295432', 'type': 'BACKGROUND', 'citation': 'Field JJ, Knight-Perry JE, Debaun MR. Acute pain in children and adults with sickle cell disease: management in the absence of evidence-based guidelines. Curr Opin Hematol. 2009 May;16(3):173-8. doi: 10.1097/MOH.0b013e328329e167.'}, {'pmid': '16883928', 'type': 'BACKGROUND', 'citation': 'Mehta SR, Afenyi-Annan A, Byrns PJ, Lottenberg R. Opportunities to improve outcomes in sickle cell disease. Am Fam Physician. 2006 Jul 15;74(2):303-10.'}, {'pmid': '1710777', 'type': 'BACKGROUND', 'citation': 'Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.'}, {'pmid': '19205968', 'type': 'BACKGROUND', 'citation': 'Conran N, Franco-Penteado CF, Costa FF. Newer aspects of the pathophysiology of sickle cell disease vaso-occlusion. Hemoglobin. 2009;33(1):1-16. doi: 10.1080/03630260802625709.'}, {'pmid': '12717457', 'type': 'BACKGROUND', 'citation': 'Jaja SI, Gbadamosi TA, Kehinde MO, Gbenebitse S. The effect of warmth or/and vitamin E supplementation on forearm blood flow and forearm vascular resistance in sickle cell and non sickle cell anaemia subjects. Niger Postgrad Med J. 2003 Mar;10(1):6-12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if warming the intravenous (IV) fluid given to patients with Sickle Cell Disease who are experiencing painful episodes known as Vaso-Occlusive Episodes; will decrease rates of hospital admission, decrease amounts of IV pain medications given, improve pain and improve global comfort.', 'detailedDescription': 'Vaso-occlusive crisis (VOC) is a common painful complication of Sickle Cell Disease and is the primary reason that these patients seek medical care in the acute care setting. This complication arises when blood vessels are obstructed by sickled red blood cells resulting in ischemic injury.\n\nThe standard management of these painful episodes comprises the administration of opioid analgesics, the infusion of intravenous (IV) fluids at room temperature and rest. These episodes often last five to seven days and many patients require inpatient management for continued administration of intravenous analgesics.\n\nThe public health impact of the disease is large as admissions frequently result in school or work absences and can be financially and emotionally taxing.\n\nIt is well established that exposure to cold precipitates VOC. For this reason, management of the pain of VOC in some centers includes the use of warming blankets as an adjunct for pain relief. It is conceptually appealing to conjecture that warm fluids might have similar salutary effects on VOC. This conjecture is bolstered by the physiologic effect of temperature on vascular tone. Specifically, it is well established that cold temperatures cause vasoconstriction whereas warm temperatures cause vasodilation. We expect that warmed fluids will similarly induce vasodilation, improving blood flow to vaso-occluded ischemic areas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vaso-occlusive Episode defined as a pain rating of 3 or above on the Wong-Baker FACES score in a child with an established diagnosis of sickle cell disease (SS, SC or S β Thalassemia)\n* 4-21 years of age\n\nExclusion Criteria:\n\n* fever (temperature greater than 38 degrees Celsius)\n* inability to complete FACES pain scale\n* evidence of acute chest syndrome clinically or radiographically\n* deemed by attending physician to be so ill as to need immediate hospital admission.'}, 'identificationModule': {'nctId': 'NCT02316366', 'briefTitle': 'The Use of Warmed Saline in Vaso-occlusive Episodes', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes', 'orgStudyIdInfo': {'id': 'IRB12-00295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Warm fluid', 'description': 'Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer', 'interventionNames': ['Device: Astoflo Plus fluid warmer']}, {'type': 'NO_INTERVENTION', 'label': 'Room temperature Fluid', 'description': 'Patients receive intravenous saline at room temperature (22-24 degrees Celsius)'}], 'interventions': [{'name': 'Astoflo Plus fluid warmer', 'type': 'DEVICE', 'description': 'A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius', 'armGroupLabels': ['Warm fluid']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Renee Quarrie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nationwide Childrens Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending', 'investigatorFullName': 'Renee Quarrie', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}