Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-22 @ 9:26 AM
Study NCT ID:
NCT02003794
Status:
TERMINATED
Last Update Posted:
2015-08-04
First Post:
2013-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'whyStopped': 'More progressive stroke in one arm', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-02', 'studyFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NIHSS ≤ 4', 'timeFrame': 'day 7 after treatment or on the day of discharge', 'description': 'Patients with good outcome by NIHSS ≤ 4 at day 7 after treatment or on the day of discharge, which ever comes first.'}], 'secondaryOutcomes': [{'measure': 'mRS ≤ 1', 'timeFrame': 'day 7 after treatment or on the day of discharge', 'description': 'Patients with mRS ≤ 1 at day 7 after treatment or on the day of discharge, which ever comes first.'}, {'measure': 'mRS ≤ 4', 'timeFrame': 'at day 90', 'description': 'Patients with mRS ≤ 4 at day 90'}, {'measure': 'mRS ≤ 1', 'timeFrame': 'at day 90', 'description': 'Patients with mRS ≤ 1 at day 90'}, {'measure': 'change of serum osmolarity', 'timeFrame': 'at day 3 after treatment', 'description': 'Percentage of change of serum osmolarity at day 3 after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute ischemic stroke', 'intravenous fluid', '้hydration'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.', 'detailedDescription': 'This study aims to find the effect of early IV fluid administration to patients with acute ischemic stroke on the neurological outcome and to determine the side effects of intravenous fluids. Due to its cost effectiveness and wide accessibility, the possible application or use of IV fluid infusion as first line treatment can aide in the treatment of more acute ischemic stroke patients worldwide. This novel information will aide physicians with more comprehensive understanding of the efficacy of utilizing IV fluid in future treatment plans for patients with acute ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age from 18-80 years\n2. NIHSS ≥ 1\n3. Diagnosis of acute ischemic stroke within 72 hours from stroke onset\n4. Enrollment into the study within 24 hours after hospital arrival\n5. Urine specific gravity level \\< 1.030\n6. Patient consent\n\nExclusion Criteria:\n\n1. Patients receiving \\> 40 ml/hr IV fluid infusion over 3 hours\n2. Acute ischemic stroke caused cardiogenic embolism\n3. Urine specific gravity ≥ 1.030\n4. Large cerebral infarction area\n\n 1. Infarction \\> 1/3 of middle cerebral artery area\n 2. Infarction \\> 1/2 of cerebellar hemisphere\n5. NHISS ≥ 18\n6. Previous or current episode of atrial fibrillation\n7. Previous or current episode congestive heart failure\n8. Previous echocardiogram with ejection fraction \\< 40%\n9. Previous or current episode of dilated cardiomyopathy\n10. Abnormal renal function GFR ≤ 60% or serum creatinine ≥ 2\n11. Modified Rankin scale before acute ischemic stroke ≥ 2\n12. Patients receiving intravenous thrombolysis\n13. NPO with need for IV fluid\n14. IV fluid infusion needed from any other causes\n15. Patients with poor prognosis with life expectancy \\< 90 days\n16. Patients involved in other ongoing clinical studies'}, 'identificationModule': {'nctId': 'NCT02003794', 'acronym': 'IVIS', 'briefTitle': 'Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)', 'orgStudyIdInfo': {'id': 'IVIS 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Fluid', 'description': '0.9% NaCl solution infusion: 100 ml/hr for three days.', 'interventionNames': ['Drug: 0.9% NaCl solution']}, {'type': 'NO_INTERVENTION', 'label': 'No IV Fluid', 'description': 'Not receive any intravenous fluid but can consume oral fluid normally for three days.'}], 'interventions': [{'name': '0.9% NaCl solution', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': '0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.', 'armGroupLabels': ['IV Fluid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Nijasri C Suwanwela, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Council of Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division of Neurology, Department of Medicine, Faculty of Medicine', 'investigatorFullName': 'Nijasri C Suwanwela', 'investigatorAffiliation': 'Chulalongkorn University'}}}}