Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT06598566
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Evaluation of Nottingham Hip Fracture Score (NHFS) and Acute Physiology and Chronic Health Evaluation (APACHE) II Score to Predict 30-day Mortality in Geriatric Patients Above 60 Years Undergoing Hip Fracture Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-15', 'studyFirstSubmitDate': '2024-09-15', 'studyFirstSubmitQcDate': '2024-09-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Mortality at least 30 days after surgery or death (during hospital stay or within 30 days after surgery.'}], 'secondaryOutcomes': [{'measure': 'Length of Stay (LOS)', 'timeFrame': '30 days', 'description': 'Length of Stay (LOS) in the hospital'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Geriatrics', 'Hip Fractures', 'APACHE II', 'Mortality', 'Morbidity'], 'conditions': ['Geriatric Hip Fracture']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years old undergoing hip fracture surgery.', 'detailedDescription': "The study aim to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years undergoing hip fracture surgery. This study was conducted at the Tata Main Hospital in Jamshedpur, India. The study was designed as a prospective observational study, with data collected from June 2022 to June 2023. The study's primary objective was to predict mortality in patients undergoing hip fracture surgery. The study also investigated secondary outcomes such as the need for postoperative ventilator and ionotropic support, the occurrence of acute kidney injury, cardiac morbidity, and the presence of pulmonary embolism and deep vein thrombosis, as well as length of stay."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted for elective surgery for fractures around the hip joint at at Tata main hospital, Jamshedpur, India', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Age more than or equal to 60 years, Underwent Hip fracture surgeries, of Either Sex\n\n\\-\n\nExclusion Criteria: Age less than 60 years of age, Hip fractures not undergoing any invasive surgery, Implant removals planned for healed hip fractures, Re-explorations during the same admission in which primary surgery was conducted\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06598566', 'briefTitle': 'A Comparative Evaluation of Nottingham Hip Fracture Score (NHFS) and Acute Physiology and Chronic Health Evaluation (APACHE) II Score to Predict 30-day Mortality in Geriatric Patients Above 60 Years Undergoing Hip Fracture Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Tata Main Hospital'}, 'officialTitle': 'A Comparative Evaluation of Nottingham Hip Fracture Score (NHFS) and Acute Physiology and Chronic Health Evaluation (APACHE) II Score to Predict 30-day Mortality in Geriatric Patients Above 60 Years Undergoing Hip Fracture Surgery.', 'orgStudyIdInfo': {'id': '2122100200'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Geriatric patients above 60 years undergoing hip fracture surgery', 'description': 'Efficacy of NHFS and APACHE-II in predicting 30-day mortality in geriatric patients above 60 years undergoing hip fracture surgery.', 'interventionNames': ['Other: Nottingham Hip Fracture Score (NHFS) score', 'Other: Acute Physiology and Chronic Health Evaluation (APACHE)-II score']}], 'interventions': [{'name': 'Nottingham Hip Fracture Score (NHFS) score', 'type': 'OTHER', 'description': 'Nottingham Hip Fracture Score (NHFS) score in patients above 60 years undergoing hip fracture surgery.', 'armGroupLabels': ['Geriatric patients above 60 years undergoing hip fracture surgery']}, {'name': 'Acute Physiology and Chronic Health Evaluation (APACHE)-II score', 'type': 'OTHER', 'description': 'Acute Physiology and Chronic Health Evaluation (APACHE)-II score in patients above 60 years undergoing hip fracture surgery', 'armGroupLabels': ['Geriatric patients above 60 years undergoing hip fracture surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '831001', 'city': 'Jamshedpur', 'state': 'Jharkhand', 'country': 'India', 'facility': 'Tata Main Hospital', 'geoPoint': {'lat': 22.80278, 'lon': 86.18545}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Being a GDPR compliant organization, data privacy officer\\'s consent may be needed. It has not been taken yet. However, masked data maybe considered if approved by the organization.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Main Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'HOD & Head Consultant, Anaesthesiology', 'investigatorFullName': 'Dr.Deb Sanjay Nag', 'investigatorAffiliation': 'Tata Main Hospital'}}}}