Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-28 @ 10:04 AM
Study NCT ID:
NCT01707303
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2012-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2012-10-10', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital length of stay, days', 'timeFrame': 'The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.', 'description': 'Hospital stay measured in days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICU', 'Critical Care', 'Intensive Care', 'Critical Illness', 'Acute Respiratory Failure', 'Mechanical Ventilation', 'Physical Therapy', 'Strength', 'Functional Status', 'Short Physical Performance Battery'], 'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50 patients and randomize to receive either two physical therapy sessions per day or usual care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength assessments and the short physical performance battery (SPPB). Study subjects will have blood for cytokine analysis through their first week of study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Mechanically ventilated via an endotracheal tube or mask\n\nExclusion Criteria:\n\n* Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)\n* Cognitive impairment prior to acute ICU illness (non-verbal)\n* Preadmit immunocompromised (\\>prednisone 20 mg/d for 2 wks)\n* Acute stroke\n* Body mass index (BMI) \\>45\n* Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)\n* Hip fracture, unstable cervical spine or pathological fracture\n* Mech vent \\>48 hours prior to transfer from an outside facility\n* Current hospitalization or transferring hospital stay \\>72 hours\n* CPR on admission, DNR on admission\n* Hospitalization within 30 days prior to admission\n* Cancer therapy within last 6 months\n* Re-admission to ICU within current hospitalization'}, 'identificationModule': {'nctId': 'NCT01707303', 'briefTitle': 'Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Effect Of Acute Inflammatory Mediators On Duration Of Functional Limitations In Patients With Acute Respiratory Failure, A Randomized, Controlled Pilot Study of Early ICU Rehabilitation Strategies', 'orgStudyIdInfo': {'id': 'IRB00000240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Usual Care', 'description': 'Usual hospital rehabilitative services', 'interventionNames': ['Other: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Early ICU Rehabilitation Strategy', 'description': 'Early ICU physical therapy will be applied in this arm', 'interventionNames': ['Other: Early ICU rehabilitation strategies']}], 'interventions': [{'name': 'Early ICU rehabilitation strategies', 'type': 'OTHER', 'otherNames': ['Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.'], 'description': 'Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II', 'armGroupLabels': ['Early ICU Rehabilitation Strategy']}, {'name': 'Usual Care', 'type': 'OTHER', 'otherNames': ['Usual Hospital Rehabilitative Services'], 'description': 'All typically applied hospital rehabilitative services applied in the usual fashion', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Peter E. Morris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}