Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-04 @ 7:00 PM
Study NCT ID:
NCT03754257
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2018-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-26', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle mass', 'timeFrame': '8 days', 'description': 'Cross-sectional area'}, {'measure': 'Muscle mass', 'timeFrame': '8 days', 'description': 'Thickness'}], 'secondaryOutcomes': [{'measure': 'Peripheral muscle strength', 'timeFrame': '8 days', 'description': "Medical Research Council Scale will be used to measure the peripheral muscle strength. The patient's effort is graded on a scale of 0-5:\n\nGrade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.\n\nGrade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side.\n\nGrade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane.\n\nGrade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.\n\nGrade 0: No movement is observed. The total score ranges from 0 (complete tetraparesis) to 60 points (normal muscle strength)."}, {'measure': 'Functional status', 'timeFrame': '8 days', 'description': 'Functional status will be assessed using the Surgical Intensive Care Unit Optimal Mobilization Score. This score classifies mobility from 0 to 4:\n\nThe SOMS "0 - No mobility" indicates that no mobilization should be considered due to the patients\' clinical status.\n\nSOMS "1 - Passive mobilization" indicates that passive mobilization can be carried out in bed.\n\nSOMS "2 - Sitting" demonstrates that the patient is already able to sit on the bed or in a chair.\n\nSOMS "3 - Standing", indicates that the patient can perform orthostatism, with or without assistance.\n\nThe highest level of SOMS "4 - Ambulation", shows that the patient is capable of ambulation.'}, {'measure': 'Inflammatory', 'timeFrame': '5 days', 'description': 'IL-1α'}, {'measure': 'Inflammatory', 'timeFrame': '5 days', 'description': 'IL-6'}, {'measure': 'Inflammatory', 'timeFrame': '5 days', 'description': 'IL-8'}, {'measure': 'Inflammatory', 'timeFrame': '5 days', 'description': 'IL-10'}, {'measure': 'Inflammatory', 'timeFrame': '5 days', 'description': 'IL-15'}, {'measure': 'Inflammatory', 'timeFrame': '5 days', 'description': 'MIP-1α'}, {'measure': 'Inflammatory', 'timeFrame': '5 days', 'description': 'TNF-α'}, {'measure': 'Inflammatory', 'timeFrame': '5 days', 'description': 'CRP'}, {'measure': 'Metabolic, damage and muscular trophism markers', 'timeFrame': '5 days', 'description': 'Lactate'}, {'measure': 'Metabolic, damage and muscular trophism markers', 'timeFrame': '5 days', 'description': 'CPK'}, {'measure': 'Metabolic, damage and muscular trophism markers', 'timeFrame': '5 days', 'description': 'IGF-1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'septic shock', 'electrical stimulation'], 'conditions': ['Sepsis', 'Septic Shock', 'SIRS']}, 'descriptionModule': {'briefSummary': 'Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results.\n\nObjective: To evaluate the effects of electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with systemic inflammatory response syndrome (SIRS), sepsis or septic shock.\n\nMethods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.\n\nExpected results: Electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with SIRS, sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.', 'detailedDescription': 'This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group.They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted to the ICU with a diagnosis of SIRS, sepsis or septic shock,\n* aged ≥ 18 years,\n* body mass index (BMI) ≤ 35 kg / m2,\n* without diabetic polyneuropathy,\n* without cardiac pacemaker,\n* without diagnosis of neuromuscular diseases,\n* absence of skin lesions.\n\nExclusion Criteria:\n\n* heart attack,\n* death.'}, 'identificationModule': {'nctId': 'NCT03754257', 'briefTitle': 'Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sirio-Libanes'}, 'officialTitle': 'Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock - Randomized, Controlled and Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': '3.999.139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Electrical Stimulation', 'description': 'Experimental Electrical Stimulation for 40 minutos + conventional physiotherapy, during seven days.', 'interventionNames': ['Procedure: Experimental Electrical Stimulation', 'Other: Conventional Physiotherapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Electrical Stimulation', 'description': 'Sham Electrical Stimulation for 40 minutes + conventional physiotherapy, during seven days.', 'interventionNames': ['Procedure: Sham Electrical Stimulation', 'Other: Conventional Physiotherapy']}], 'interventions': [{'name': 'Experimental Electrical Stimulation', 'type': 'PROCEDURE', 'description': 'Experimental Electrical Stimulation (100Hz) during 40 minutes', 'armGroupLabels': ['Experimental Electrical Stimulation']}, {'name': 'Sham Electrical Stimulation', 'type': 'PROCEDURE', 'description': 'Sham Electrical Stimulation (5Hz) during 40 minutes', 'armGroupLabels': ['Sham Electrical Stimulation']}, {'name': 'Conventional Physiotherapy', 'type': 'OTHER', 'description': 'Active and passive exercises, and walking.', 'armGroupLabels': ['Experimental Electrical Stimulation', 'Sham Electrical Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01308050', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Sírio-Libanês', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sirio-Libanes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Wellington Pereira dos Santos Yamaguti', 'investigatorFullName': 'Wellington Yamaguti', 'investigatorAffiliation': 'Hospital Sirio-Libanes'}}}}