Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-04 @ 8:51 AM
Study NCT ID:
NCT02544256
Status:
WITHDRAWN
Last Update Posted:
2016-10-18
First Post:
2015-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mild Hypothermia During Intracranial Aneurysm Clipping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007036', 'term': 'Hypothermia, Induced'}], 'ancestors': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'higher mortality in another published study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2015-09-05', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Days of hospital stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}, {'measure': 'Glasgow outcome score (GOS) on discharge', 'timeFrame': '2 weeks after operation'}], 'primaryOutcomes': [{'measure': 'Changes in Sidestream Dark Field (SDF) imaging variables', 'timeFrame': '1 and 2 hours after skin incision', 'description': 'brain microcirculation will be measured by sidestream-dark field imaging (SDF) probe'}], 'secondaryOutcomes': [{'measure': 'Changes in diameter of small brain arteries at operating site', 'timeFrame': '1 and 2 hours after skin incision', 'description': 'will be measured by SDF probe'}, {'measure': 'Occurrence of vasospasms', 'timeFrame': 'within the first 14 days after surgery', 'description': 'measured by transcranial Doppler'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Microcirculation', 'Mild Hypothermia, Induced', 'Subarachnoid Hemorrhage, Aneurysmal', 'Aneurysmal Clipping', 'Vasospasms'], 'conditions': ['Subarachnoid Hemorrhage, Aneurysmal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether mild hypothermia causes reduction of vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of vasospasms during the period of 14 postoperative days measured by transcranial Doppler.', 'detailedDescription': 'Methods: All the patients meeting the study criteria will be randomized into two groups. Normothermia (NT) group : during the whole period of surgery the body temperature will be maintained in the range 35.8° C - 36.8° C. Hypothermia (HT) group: After induction to general anaesthesia the patients will be cooled to body temperature 33.8° C - 34.8° and this temperature maintained up to the end of microcirculation measurement after aneurysm clipping. Warming up of the patients will start immediately afterwards. The target temperature at the time of extubation will be over 36° C in both groups (one of the extubation criteria).\n\nSpecific management: No pharmacological sedation (premedication) will be given to the patients. Cooling/warming mattress/blanket (PlastiPad® Blanketrol® III Cincinnati Sub-Zero, USA) will be placed on the operating table. Induction to general anesthesia will be with propofol 2 mg/kg/b.w i.v. (with possible adjustment according to age and/or physical status of the patient) and atracurium 0,5 mg/kg/b.w. i.v. After orotracheal intubation, the esophageal temperature probe will be inserted (depth of insertion 25 cm from the nostril). Afterwards, the envelope with randomization will be opened by the anaesthesiologist.\n\nIn HT group, the targeted body temperature will be set to 33° C and a bolus of saline 250 ml cooled to 5° C will be administered.\n\nIn NT group, the targeted body temperature will be set to 36° C and a bolus of saline 250 ml warmed to 37° C using infusion heater will be administered.\n\nStandard preparation for the surgery will continue afterwards (insertion of central venous catheter, arterial catheter, urinary catheter). After finishing the preparation (coming of the surgeon), the infusion of mannitol 15% at the dose 0,5 g/kg i.v. is started and set for the duration of 40 minutes. Monitoring: basic monitoring (SpO2, ECG, end-tidal carbon dioxide (EtCO2), NIBP) together with extended monitoring (invasive blood pressure, response entropy/state entropy (RE/SE), neuromuscular transmission module (NMT), surgical plethysmography index (SPI).\n\nAnesthesia management: Desflurane anesthesia in O2/air mixture with concentration of oxygen (FiO2) 0.45 will be used with targeted concentrations of desflurane according to the age groups initially (to achieve end-tidal concentration of desflurane 6 V%, 5.5 V%, 5 V%, 4.5 V%, and 4 V% in age groups 18 - 30, 30 - 40, 40 - 55, 55 - 65, and over 65 years respectively), further adjustment will be done to keep target RE/SE 40-50 in the individual patient. Analgesia will be provided by bolus i.v. administration of remifentanil 80 ug before induction, followed by continuous administration 0.25 ug/kg/min initially with further stepwise adjustment according to SPI (3-5 ml/hour steps). Target analgesia according to SPI is defined as the initial figure of SPI recorded 5 minutes after induction plus 10 points. Figures of SPI exceeding for 1 minute the target figure indicate the need of increasing the rate of remifentanil infusion. Atracurium boluses will be used for muscle relaxation, NMT monitoring by train of four (TOF) will be done in 5 minute intervals, TOF count over 1 indicating need of further atracurium bolus. Starting from dura mater suture, no further boluses of atracurium will be given.\n\nHemodynamic stability: Systolic and mean arterial pressures are maintained in the range of ± 15% of usually measured BP for individual patient. Decrease of BP bellow this figure in the duration of at least 5 minutes is indication for continuous administration of noradrenaline. Nimodipine is administered continuously during the whole procedure, infusion rate is set at the ICU, no adjustments are indicated at the OR. Volume therapy is provided by continuous balanced isotonic crystalloid infusion 5 ml/kg/h.\n\nMicrocirculation measurement: After craniotomy, microcirculation will be measured by SDF probe at the labelled sites of the brain (edge of craniotomy and at the distance of 2 cm from aneurysm). After aneurysm clipping, the measurement will be repeated at the same sites.\n\nFinishing anaesthesia: At the beginning of skin suture, the remifentanil infusion is stopped. After finishing the skin suture, the administration of desflurane is stopped and end-tidal control flush out of desflurane is activated.\n\nExtubation criteria: consciousness Glasgow coma scale (E-2-3/V-1-3/M-6), normotension including noradrenaline administration in stable continuous dose, normocapnia, spontaneous ventilation with respiratory rate (RR) over 10/minute, tidal volume (TV) 4-6 ml/kg, preserved coughing reflex, SpO2 over 95% without/with O2 administration, normothermia over 36° C, train of four ratio over 92%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute subarachnoidal hemorrhage based on ruptured aneurysm\n* Hunt and Hess scale 1-4\n* Clipping up to 72 hours after the rupture\n\nExclusion Criteria:\n\n* Known cryoglobulinemia'}, 'identificationModule': {'nctId': 'NCT02544256', 'briefTitle': 'Mild Hypothermia During Intracranial Aneurysm Clipping', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Hradec Kralove'}, 'officialTitle': 'Mild Hypothermia During Intracranial Aneurysm Clipping: Effect on Brain Microcirculation and Postoperative Vasospasms in Patients With Ruptured Aneurysms', 'orgStudyIdInfo': {'id': '201507-S16P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild hypothermia', 'description': 'After induction to general anaesthesia the patients will be cooled to 33° C. Targeted body temperature 33,8° C - 34,8° will be maintained up to the end of microcirculation measurement after aneurysm clipping.', 'interventionNames': ['Procedure: Mild hypothermia']}, {'type': 'NO_INTERVENTION', 'label': 'Normothermia', 'description': 'The body temperature will be maintained in the range 35,8° C - 36,8° C.'}], 'interventions': [{'name': 'Mild hypothermia', 'type': 'PROCEDURE', 'description': 'Mild hypothermia during surgical clipping of brain aneurysm will be reached by cooling to body temperature 33,8° C - 34,8° and this temperature maintained up to the end of microcirculation measurement after aneurysm clipping.', 'armGroupLabels': ['Mild hypothermia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}], 'overallOfficials': [{'name': 'Vlasta Dostalova, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Hradec Kralove'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Hradec Kralove', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dostalova Vlasta, MD, PhD', 'investigatorFullName': 'Dostalova Vlasta, MD, PhD', 'investigatorAffiliation': 'University Hospital Hradec Kralove'}}}}