Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-30 @ 4:27 AM
Study NCT ID:
NCT01104857
Status:
UNKNOWN
Last Update Posted:
2015-06-10
First Post:
2010-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Dysfunction in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-04-14', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm muscle myosin content', 'timeFrame': '1 day'}, {'measure': 'Markers for inflammation', 'timeFrame': '1 day', 'description': 'Inflammatory mediators are measured in plasma and diaphragm at the moment the diaphragm biopsy is obtained.'}, {'measure': 'Markers for activation of proteolytic pathway in the diaphragm', 'timeFrame': '1 day', 'description': 'Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal).'}], 'secondaryOutcomes': [{'measure': 'length of ICU stay', 'timeFrame': '6 months', 'description': 'Length of ICU stay obtained from medical record'}, {'measure': 'Length of mechanical ventilation', 'timeFrame': '6 months', 'description': 'Duration of mechanical ventilation is assesssed within 6 months after obtaining diaphragm biopsy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory muscle', 'Myosin', 'Mechanical ventilation'], 'conditions': ['Sepsis', 'Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'Respiratory muscle dysfunction in critically ill patients is associated with elevated morbidity, including prolonged weaning from mechanical ventilation. The causes for respiratory muscle dysfunction in these patients is poorly understood and no effective treatment is available.\n\nThe general hypothesis of the present study is that in critically ill mechanically ventilated subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of proteolytic cascades.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe sepsis / septic shock\n* Clinical reason for laparotomy\n* \\> 18 years\n\nExclusion Criteria:\n\n* No informed consent\n* Medical history of myopathy\n* Unintended weight loss before ICU admission\n* Pregnancy\n* Chronic use of corticosteroids'}, 'identificationModule': {'nctId': 'NCT01104857', 'briefTitle': 'Respiratory Muscle Dysfunction in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Nijmegen'}, 'orgStudyIdInfo': {'id': 'Diam1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diaphragm muscle biopsy', 'description': 'Patients admitted to the ICU meeting severe sepsis / septic shock criteria', 'interventionNames': ['Procedure: diaphragm muscle biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Elective laparotomy', 'interventionNames': ['Procedure: Diaphragm muscle biopsy']}], 'interventions': [{'name': 'diaphragm muscle biopsy', 'type': 'PROCEDURE', 'description': 'Biopsy is obtained for biochemical analysis', 'armGroupLabels': ['Diaphragm muscle biopsy']}, {'name': 'Diaphragm muscle biopsy', 'type': 'PROCEDURE', 'description': 'Biopsy is obtained for biochemical analysis', 'armGroupLabels': ['Elective laparotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud Universtity Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Nijmegen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Leo Heunks', 'investigatorAffiliation': 'University Medical Center Nijmegen'}}}}