Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT03431402
Status:
UNKNOWN
Last Update Posted:
2018-03-14
First Post:
2018-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-02-10', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in national institute of health stroke score before and after treatment with hyperbaric oxygen therapy', 'timeFrame': '2 years', 'description': 'The national institute of health stroke score (NIHSS) is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Maximum score of 42) "Mild" disease was defined as score of 0-14, "moderate" as 15-28, and "severe" as 29-42.\n\nAs pretreatment evaluation, all patients will be evaluated by national institute of health stroke score within 48 hours after admission.\n\nAs posttreatment evaluation, patients in the hyperbaric oxygen therapy group were evaluated by national institute of health stroke score after 10 sessions of hyperbaric oxygen therapy.\n\nThe control group was evaluated with national institute of health stroke score 10 days after stroke onset.\n\nOne month after treatment, all patients were evaluated again using the national institute of health stroke score.'}], 'secondaryOutcomes': [{'measure': 'Hospital mortality', 'timeFrame': '2 years'}, {'measure': 'Hospital length of stay', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': 'Background and Rationale:\n\nCerebrovascular disease is always ranked at the top causes of death and most of hospitalized acute stroke patients have ischemic stroke \\[1\\].\n\nAlthough the mortality rate of acute ischemic stroke is less than that of hemorrhagic stroke \\[1\\], it still results in patient disabilities and complications that often lead to significant costs to individuals, families, and society.\n\nTraditional treatment for acute ischemic stroke includes thrombolytic therapy by injecting tissue plasminogen activator (t-PA) within three hours after onset of symptoms \\[2\\], antiplatelets and/or anticoagulant agents administered within the first 48 hours. Clinically, the narrow time window of thrombolytic therapy and coexisting contraindications limit the use of t-PA \\[2\\]. Thus, searching for an effective supplemental treatment for acute ischemic stroke is imperative.\n\nHyperbaric oxygen therapy (HBOT) is valuable in treating acute carbon monoxide poisoning \\[3,4\\], air or gas embolism \\[5\\], facilitating wound healing \\[6\\] and has been used as an adjuvant treatment for many neurological disorders that need further study as concussion \\[7\\] , stroke \\[8,9\\], cerebral palsy \\[ 10\\],traumatic brain injury \\[ 11\\], cerebral air embolism \\[12\\], Autism \\[13\\] and multiple sclerosis \\[14\\].\n\nIndications of hyperbaric oxygen therapy recommended by undersea and hyperbaric medical society (UHMS) \\[15\\] are 1.air or gas embolism \\[5\\], 2.carbon monoxide poisoning \\[3,4\\], 3.clostridial myositis and myonecrosis \\[16\\], 4.crush injury, compartment syndrome and other acute traumatic ischemias \\[17\\], 5.decompression sickness \\[18\\], 6.arterial insufficiencies \\[19\\], 7.severe anemia \\[20\\], 8.intracranial abscess \\[21\\], 9.necrotizing soft tissue infections \\[22\\],10. refractory osteomyelitis \\[23\\], 11.delayed radiation injury \\[24\\], 12.compromised grafts and flaps \\[25\\], 13.acute thermal burn injury \\[26\\] and 14.idiopathic sudden sensorineural hearing loss \\[27\\].\n\nKnown mechanisms of HBOT-induced neuroprotection include enhancing neuronal viability via increased tissue oxygen delivery to the area of diminished blood flow, reducing brain edema, and improving metabolism after ischemia \\[28,29\\]. Furthermore, a recent study performed on a rat suggested that upregulation of the expression of glial derived neurotrophic factor (GDNF) and nerve growth factor (NGF) might underlie the effect of HBOT \\[30\\].\n\nThe effectiveness of use of Hyperbaric oxygen therapy in human ischemic stroke is still controversial that need further evaluation.', 'detailedDescription': 'Study Methods:\n\nStudy Population A 60 adult (aged \\>18 years) patients were included with a diagnosis of acute thromboembolic ischemic stroke within 48 hours after onset, according to clinical picture and imaging findings by brain computed tomography (CT) without evidence of hemorrhage, upon admission to the hospital and no patient received thrombolytic therapy.\n\nInclusion criteria:\n\nGroup one, HBOT group (n = 30): thirty adult patients with acute ischemic stroke will receive conventional medical treatment ( as antiplatelet but not thrombolytic therapy) with 10 sessions of adjunctive hyperbaric oxygen therapy (HBOT) within 3-5 days after the onset of stroke .\n\nCompared with Group two, control group(n = 30): thirty adult patients with acute ischemic stroke will receive conventional medical treatment alone.\n\nThe baseline clinical characteristics were similar in both groups.\n\nExclusion criteria:\n\n* Patient with cerebral hemorrhage\n* Patient received thrombolytic therapy\n* Emphysema with carbon dioxide retention\n* Pneumothorax\n* Seizure disorder\n* Uncontrolled high fever\n\nDemographic Characteristics:\n\nAdults more than 18 years, Any gender. All patients upon admission to the hospital will provide:\n\nComplete history taking:Age, Gender, Smoking, Alcohol consumption, Past history: diabetes mellitus , hypertension , Chronic obstructive pulmonary disease, Epilepsy or cardiovascular disease.\n\nNeurological assessment use NIHSS score Blood tests:Complete blood count , Coagulation profile, Fasting blood sugar., Renal function test (Urea and creatinine).\n\nCT brain\n\nChest x-ray :\n\nElectrocardiogram (ECG):'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patients with acute ischemic stroke\n* Glasgow coma scale more than 10\n\nExclusion criteria:\n\n* Patient with cerebral hemorrhage\n* Patient received thrombolytic therapy\n* Emphysema with carbon dioxide (CO2) retention\n* Pneumothorax\n* Seizure disorder'}, 'identificationModule': {'nctId': 'NCT03431402', 'briefTitle': 'Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke', 'orgStudyIdInfo': {'id': 'KasrELAiniH critical care dep.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Acute stroke receive hyperbaric oxygen', 'interventionNames': ['Drug: Hyperbaric oxygen']}, {'type': 'NO_INTERVENTION', 'label': 'Acute stroke receive only conventional treatment'}], 'interventions': [{'name': 'Hyperbaric oxygen', 'type': 'DRUG', 'description': '\\- HBOT group will receive 10 sessions of HBOT at 2.0 Atmosphere absolute (ATA) for one hour in a hyperbaric chamber pressured with compressed air, whereby patients will breath 100% oxygen to 2 ATA started within 3-5days after the onset of stoke plus conventional therapy as antiplatelets therapy, correction of hypovolaemia , hypoxia and adequate nutrition', 'armGroupLabels': ['Acute stroke receive hyperbaric oxygen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ibrahim Shehata, MSC', 'role': 'CONTACT', 'email': 'shehata772@gmail.com'}, {'name': 'Shereen Elgengeehy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tamer Fahmy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mahmoud Kenawi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'waleed Farouk, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ibrahim Shehata Hussin', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ibrahim Shehata, MSC', 'role': 'CONTACT', 'email': 'shehata772@gmail.com', 'phone': '001011946001'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of critical care medicine', 'investigatorFullName': 'Tamer Salah aldin Fahmy', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}