Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-11 @ 10:38 PM
Study NCT ID:
NCT02972918
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2016-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative levosimendán and Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077464', 'term': 'Simendan'}], 'ancestors': [{'id': 'D006835', 'term': 'Hydrazones'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011724', 'term': 'Pyridazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effects of Levosimendan on left ventricular function.', 'timeFrame': 'Baseline and every 24 hours postoperative, 48 h postoperative, and 7 days and after 30 days postoperative.', 'description': 'Changes of left ventricular function as assessed transthoracic.'}, {'measure': 'Change in cardiac index', 'timeFrame': '48 hours after start of iv infusion', 'description': 'Measured through arterial pulse wave analysis. A baseline measurement is done before infusion is started'}], 'secondaryOutcomes': [{'measure': 'Changes in transport and tissue perfusion of oxygen', 'timeFrame': '1 to 2 day postoperative', 'description': 'measured by arterial and venous blood gases'}, {'measure': 'Changes in renal function', 'timeFrame': '1 to 7 days postoperative', 'description': 'Proportion of subjects who develop AKIN stage 1 (increase \\> 0.3 mg/dl or \\> 25% in serum creatinine from previous visit)'}, {'measure': 'Changes in NT-proBNP and troponin I', 'timeFrame': '24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative', 'description': 'Plasma NT-proBNP levels were measured'}, {'measure': 'Number of patients with adverse.', 'timeFrame': '30 days postoperative', 'description': 'Development of arrhythmias'}, {'measure': 'Number of patients with adverse.', 'timeFrame': '30 days postoperative', 'description': 'Occurence of nausea/vomiting'}, {'measure': 'Number of patients with adverse event.', 'timeFrame': '30 days postoperative', 'description': 'Occurence of headache'}, {'measure': 'Use of high inotropes (dopamine, Norepinephrine)', 'timeFrame': 'after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit', 'description': 'during postoperative unit stay.'}, {'measure': 'morbidity', 'timeFrame': '3 months', 'description': 'All cause'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': '1st-30th postoperative day', 'description': 'Perioperative heart failure infarction, stroke'}, {'measure': 'Time on mechanical ventilation', 'timeFrame': '1st-30th postoperative day', 'description': 'Perioperative heart failure infarction, stroke'}, {'measure': 'mortality', 'timeFrame': 'measured at 3 months', 'description': 'All cause'}, {'measure': 'Perioperative mortality', 'timeFrame': '7 days postoperative', 'description': 'All cause'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ventricular Dysfunction, Left', 'Hip Fracture']}, 'referencesModule': {'references': [{'pmid': '11069188', 'type': 'RESULT', 'citation': 'Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61. doi: 10.1007/s001980070075.'}, {'pmid': '10093980', 'type': 'RESULT', 'citation': 'Center JR, Nguyen TV, Schneider D, Sambrook PN, Eisman JA. Mortality after all major types of osteoporotic fracture in men and women: an observational study. Lancet. 1999 Mar 13;353(9156):878-82. doi: 10.1016/S0140-6736(98)09075-8.'}, {'pmid': '19054201', 'type': 'RESULT', 'citation': 'Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jorgensen HL, Duus BR, Lauritzen JB; Hip Fracture Group of Bispebjerg Hospital. A comprehensive hip fracture program reduces complication rates and mortality. J Am Geriatr Soc. 2008 Oct;56(10):1831-8. doi: 10.1111/j.1532-5415.2008.01945.x.'}, {'pmid': '18405408', 'type': 'RESULT', 'citation': 'Ponschab M, Hochmair N, Ghazwinian N, Mueller T, Plochl W. Levosimendan infusion improves haemodynamics in elderly heart failure patients undergoing urgent hip fracture repair. Eur J Anaesthesiol. 2008 Aug;25(8):627-33. doi: 10.1017/S0265021508004080. Epub 2008 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters.', 'detailedDescription': 'Hip fracture is a very predominant entity in elderly patients and it is one of the most frequent cause of admission in a hospital.\n\nElderly patients undergoing surgery for hip fracture have a high risk of morbidity and mortality in the postoperative. Several studies have shown that there is a high risk of cardiovascular complications in this group of patients and 3-months mortality is 15-20%. One of the causes of this high morbidity and mortality is the high incidence of chronic cardiac failure in this patients. The goal of the present study is to evaluate if the optimization of preoperative cardiac function with levosimendan in patients with left ventricular ejection fraction \\< 45% can improve haemodynamic and the tissue perfusion values, and reduce cardiac morbidity and mortality 3 months postoperatively.\n\nFollowing written consent, the patients with left ventricular ejection fraction \\< 45% will be admitted in the resuscitation and anaesthesia room where they will receive a levosimendan intravenous injection undergoing a strict haemodynamic vigilance.\n\nBefore the levosimendan intravenous injection the patients firs have an echocardiography to evaluate myocardial function, NT-proBNP. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a ProAQT sensor system ( PULSION , Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), cardiac power index (CPI).The levosimendan will be administered like a continues injection during 24 hours (0,1 mcg/kg/min) without initial dose. Following the optimization the patients will be transferred to the operating room in the next 3 days and will come back to the resuscitation and anaesthesia room where they will stay 24 hours more if there is no any complication.\n\nAll the cardiac complications will be documented and follw-up will be done by after 30 days and 3 months postoperative.\n\nThe patients will be selected for more than 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients with chronic heart failure of any etiology with hip fracture that present an acute descompendation of their chronic heart failure and need inotropes because of the conventional treatment is not enough', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients due to undergo urgent of hip fracture.\n2. Patients with cardiac failure (EF \\< 45 %).\n3. Decompensated heart failure.\n4. Informed consent provided by the patient.\n\nExclusion Criteria:\n\n1. \\<18 years old\n2. Emergency surgery\n3. Serious aortic stenosis (\\< 1 cm2)\n4. Sustained ventricular tachycardia or atrial fibrillation \\>140\n5. Earlier episodes of "torsades depointes"\n6. Systolic blood pressure \\< 85 mmHg\n7. Serious kidney failure (GFR \\< 30 ml/min)\n8. Serious liver failure (known class C Child-Pugh score)\n9. Allergy levosimendan'}, 'identificationModule': {'nctId': 'NCT02972918', 'acronym': 'OPL', 'briefTitle': 'Preoperative levosimendán and Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario de Canarias'}, 'officialTitle': 'Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture', 'orgStudyIdInfo': {'id': 'MML-LEV-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Levosimendan', 'description': 'At least 12 hours before surgery: Infusion of levosimendan (0,1 mcg/kg/min). 24 hours of infusion without a bolus.', 'interventionNames': ['Drug: Levosimendan']}], 'interventions': [{'name': 'Levosimendan', 'type': 'DRUG', 'otherNames': ['Simdax.'], 'description': '24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)', 'armGroupLabels': ['Levosimendan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'state': 'S/C Tenerife', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Canarias', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}], 'overallOfficials': [{'name': 'María del Carmen Martín Lorenzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Canarias'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario de Canarias', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'María del Carmen Martín Lorenzo', 'investigatorAffiliation': 'Hospital Universitario de Canarias'}}}}