Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT01141894
Status:
TERMINATED
Last Update Posted:
2020-09-18
First Post:
2010-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D000092526', 'term': 'Proximal Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004280', 'term': 'Dobutamine'}, {'id': 'C485123', 'term': 'HES 130-0.4'}, {'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'whyStopped': 'slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2010-04-20', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with postoperative complications', 'timeFrame': 'up to 2 weeks', 'description': 'absolute value, number'}], 'secondaryOutcomes': [{'measure': 'Health Related Quality of Life', 'timeFrame': '1 year', 'description': 'European Quality of Life questionaire using five dimensions (EQ-5D)shall be registered preoperatively, at 4 and 12 months postoperatively'}, {'measure': 'number of complications', 'timeFrame': '4 months', 'description': 'absolute value number'}, {'measure': 'number of complications', 'timeFrame': '12 months', 'description': 'absolute value number'}, {'measure': 'health related quality of life', 'timeFrame': '4 months'}, {'measure': 'health related quality of life', 'timeFrame': '12 months', 'description': 'absolute value number'}, {'measure': 'haemodynamic parameters', 'timeFrame': 'baseline', 'description': 'monitor readings from LiDCO plus'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Proximal Femoral Fracture'], 'conditions': ['Femoral Fracture']}, 'referencesModule': {'references': [{'pmid': '26994228', 'type': 'DERIVED', 'citation': 'Bartha E, Arfwedson C, Imnell A, Kalman S. Towards individualized perioperative, goal-directed haemodynamic algorithms for patients of advanced age: observations during a randomized controlled trial (NCT01141894). Br J Anaesth. 2016 Apr;116(4):486-92. doi: 10.1093/bja/aew025.'}, {'pmid': '23837606', 'type': 'DERIVED', 'citation': 'Bartha E, Davidson T, Brodtkorb TH, Carlsson P, Kalman S. Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients. Trials. 2013 Jul 9;14:205. doi: 10.1186/1745-6215-14-205.'}]}, 'descriptionModule': {'briefSummary': "The investigators aimed to compare the costs and consequences of 'routine perioperative fluid therapy' and 'GDHT in terms of morbidity, mortality, length of hospital stay, activity of daily living, health related quality of life, cognitive functions and need of social services and up till 12 months following operations of proximal femoral fracture at elderly. The primary hypothesis is that 'GDHT is a better strategy than 'routine fluid therapy' in terms of reduced frequency of postoperative complications.", 'detailedDescription': "The investigation is an open, randomized clinical study of individuals suffering from a proximal femoral fracture. The total study duration for each subject is approximately 12 months (+- 1 month); each patient will have 4'visits' (i.e. when PI extracts data to database) including regular praxis total: at registration; at discharge; 4 months and finally at 12 months after the surgery. For practical and logistic reasons, an interim-analysis will be conducted after approximately 100 patients whose data are completed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (men and women) age ≥ 70 years\n* Patients´ scheduled for operation of proximal femoral fracture during office hours\n* Patient who have a witnessed or written informed consent\n\nExclusion Criteria:\n\nAny of the following is regarded as a criterion for exclusion from the study:\n\n* Concomitant medication with Lithium\n* Known allergy (or hypersensitivity) to Lithium, or components of the medical device\n* Weight ≤ 40 kg\n* Other conditions or symptoms preventing the subject from entering the study, according to investigators judgment\n* Life expectancy less than 6 months and/or pathological fractures\n* Not possible to insert arterial line.'}, 'identificationModule': {'nctId': 'NCT01141894', 'acronym': 'GDHT', 'briefTitle': 'Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Evaluation of Costs and Consequences of Alternative Strategies of Intraoperative Fluid and Pharmacological Optimization. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2009-018087-10'}, 'secondaryIdInfos': [{'id': 'ID: 2008-1240-31', 'type': 'OTHER', 'domain': 'Ethical Board of Karolinska Institute Stockholm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Routine fluid treatment', 'description': "Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h and additionally as needed Voluven at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension", 'interventionNames': ['Other: Routine fluid treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Goal directed haemodynamic treatment', 'description': "Goal directed haemodynamic treatment Dobutamine 0.2-10 μg/kg/min Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h Voluven 3 ml/kg as fluid challenge at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension", 'interventionNames': ['Other: Goal directed haemodynamic treatment']}], 'interventions': [{'name': 'Goal directed haemodynamic treatment', 'type': 'OTHER', 'otherNames': ['Dobutamine 0.2-10 μg/kg/min', 'Buffered Glucose 25 mg/ml 1 ml/kg/h', 'Ringer´s Acetate 2 ml/kg/h', 'Voluven 3 ml/kg as fluid challenge', 'Phenylephrine 50 μg for correction of hypotension'], 'description': 'Treatment by fluids and Dobutamine to attain fixed haemodynamic goal', 'armGroupLabels': ['Goal directed haemodynamic treatment']}, {'name': 'Routine fluid treatment', 'type': 'OTHER', 'otherNames': ['Buffered Glucose 25 mg/ml 1ml/kg/h', 'Ringer´s Acetate 2 ml/kg/h', "Voluven at the attending anaesthetist's discretion", 'Phenylephrine 50 μg for correction of hypotension'], 'description': 'Protocol guided fluid treatment used in the clinical routine', 'armGroupLabels': ['Routine fluid treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Huddinge', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}], 'overallOfficials': [{'name': 'Erzsebet Bartha, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Erzsebet Bartha', 'investigatorAffiliation': 'Karolinska Institutet'}}}}