Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-03-13 @ 8:10 PM
Study NCT ID:
NCT03237351
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2017-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005440', 'term': 'Fluid Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-21', 'studyFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2017-07-30', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Oxygenation Index in 48 hours', 'timeFrame': 'Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation'}], 'secondaryOutcomes': [{'measure': 'The duration of surgery', 'timeFrame': 'During surgery period'}, {'measure': 'The duration of mechanical ventilation', 'timeFrame': 'During surgery period'}, {'measure': 'Crystalloid administered', 'timeFrame': 'During surgery period'}, {'measure': 'Colloid administered', 'timeFrame': 'During surgery period'}, {'measure': 'Blood loss', 'timeFrame': 'During surgery period'}, {'measure': 'Urine output', 'timeFrame': 'During surgery period'}, {'measure': 'Number of patients received vasopressor', 'timeFrame': 'During surgery period'}, {'measure': 'Blood pressure', 'timeFrame': 'Before the surgery and 48 hours after surgery'}, {'measure': 'Leukocyte', 'timeFrame': 'Before the surgery and 48 hours after surgery'}, {'measure': 'Hematocrit', 'timeFrame': 'Before the surgery and 48 hours after surgery'}, {'measure': 'Complication until hospital discharge', 'timeFrame': '1 month after surgery'}, {'measure': 'Hospital stay postoperatively', 'timeFrame': '1 month after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['goal-directed fluid therapy', 'thoracic surgery, video-assisted', 'acute lung injury'], 'conditions': ['Goal-directed Fluid Therapy']}, 'referencesModule': {'references': [{'pmid': '19837807', 'type': 'BACKGROUND', 'citation': 'Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.'}, {'pmid': '19602972', 'type': 'BACKGROUND', 'citation': 'Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.'}, {'pmid': '26440438', 'type': 'BACKGROUND', 'citation': 'Ripolles-Melchor J, Espinosa A, Martinez-Hurtado E, Abad-Gurumeta A, Casans-Frances R, Fernandez-Perez C, Lopez-Timoneda F, Calvo-Vecino JM. Perioperative goal-directed hemodynamic therapy in noncardiac surgery: a systematic review and meta-analysis. J Clin Anesth. 2016 Feb;28:105-15. doi: 10.1016/j.jclinane.2015.08.004. Epub 2015 Oct 2.'}, {'pmid': '23719773', 'type': 'BACKGROUND', 'citation': 'Chau EH, Slinger P. Perioperative fluid management for pulmonary resection surgery and esophagectomy. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):36-44. doi: 10.1177/1089253213491014. Epub 2013 May 29.'}, {'pmid': '23917675', 'type': 'BACKGROUND', 'citation': 'Zhang J, Chen CQ, Lei XZ, Feng ZY, Zhu SM. Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobectomy operations: a pilot study. Clinics (Sao Paulo). 2013 Jul;68(7):1065-70. doi: 10.6061/clinics/2013(07)27.'}, {'pmid': '21088596', 'type': 'BACKGROUND', 'citation': 'Lee JH, Jeon Y, Bahk JH, Gil NS, Hong DM, Kim JH, Kim HJ. Pulse pressure variation as a predictor of fluid responsiveness during one-lung ventilation for lung surgery using thoracotomy: randomised controlled study. Eur J Anaesthesiol. 2011 Jan;28(1):39-44. doi: 10.1097/EJA.0b013e32834089cf.'}]}, 'descriptionModule': {'briefSummary': 'Perioperative fluid management is a key component of anesthetic management during thoracic surgery. On one hand, fluid restriction could compromise perfusion of vital organs and surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary complications, notably pulmonary edema, which carries a high mortality rate. Perioperative fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed. Therefore, to achieve the balance between preventing fluid overload and optimising organ perfusion, the practical index to guide fluid management, which can predict whether fluid loading will improve haemodynamic conditions in an individual patient, would be very valuable during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory variations of arterial pressure \\[i.e. pulse pressure variation (PPV) and systolic pressure variation\\] can predict fluid responsiveness in mechanically ventilated patients under various conditions. Therefore, pressure variations are increasingly being advocated for fluid management.This study will discuss the effects of pulse pressure variation(PPV) in different level during anesthesia on patients with oxygenation index and short-term prognosis undergoing video-assisted thoracoscopic surgery for pneumoresection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status I-III; aged 18-60 years old; BMI 18.5 \\~ 28 kg/m2\n\nExclusion Criteria:\n\n* Refused to participate in the experiment, hepatic/renal/cardiac dysfunction, severe valvular disease, frequent arrhythmia, moderate anemia and severe electrolyte disturbance before operation.'}, 'identificationModule': {'nctId': 'NCT03237351', 'briefTitle': 'Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection', 'organization': {'class': 'OTHER', 'fullName': "Shenzhen Second People's Hospital"}, 'officialTitle': 'Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2017041102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional therapy group', 'description': 'Patients in Conventional therapy group were received fluid therapy: intraoperative transfusion volume=maintenance fluids+deficit replacement+restoration of losses and with heart rate, mean arterial pressure, urine measurement ect.', 'interventionNames': ['Device: Fluid therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Low value of PPV group', 'description': 'Patients in low value of PPV group were received fluid therapy according to PPV (3% ≤PPV \\< 5%) .', 'interventionNames': ['Device: Fluid therapy']}, {'type': 'EXPERIMENTAL', 'label': 'High value of PPV group', 'description': 'Patients in high value of PPV group were received fluid therapy according to PPV (5% ≤PPV \\< 8%) .', 'interventionNames': ['Device: Fluid therapy']}], 'interventions': [{'name': 'Fluid therapy', 'type': 'DEVICE', 'description': 'Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.', 'armGroupLabels': ['Conventional therapy group', 'High value of PPV group', 'Low value of PPV group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518035', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen Second People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZhiHeng Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chair of Department of Anesthesiology', 'investigatorFullName': 'ZhiHeng Liu', 'investigatorAffiliation': "Shenzhen Second People's Hospital"}}}}