Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT03193320
Status:
UNKNOWN
Last Update Posted:
2020-03-03
First Post:
2017-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Intraoperative Fluids in Ambulatory Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be under general anesthesia during the interventions. Outcome assessors (nurses) will be blinded to the treatment provided in the operating rooms'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 243}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2017-06-15', 'studyFirstSubmitQcDate': '2017-06-16', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total volume of fluid infused intraoperatively', 'timeFrame': '0 min after extubation', 'description': 'Total volume of ringer lactate solution infused intraoperatively to participants (ml).'}, {'measure': 'Time to discharge', 'timeFrame': '240 min after extubation (discharge)', 'description': 'Time in hours (h) from anesthesia reversal to fulfillment of patient discharge criteria. Patients will be assessed by an attending nurse every 30 min to assess the fulfillment of these criteria.'}], 'secondaryOutcomes': [{'measure': 'Significant postoperative nausea and vomiting (PONV)', 'timeFrame': '240 min after extubation (discharge)', 'description': 'Presence of significant PONV as determined by a score ≥5 on the scale proposed by Myles SA et al. (BJA 2012)'}, {'measure': 'Postoperative dizziness', 'timeFrame': '30 min after reversal', 'description': 'Presence of patient self-reported dizziness in the post-operative period.'}, {'measure': 'Postoperative fatigue', 'timeFrame': '30 min after reversal', 'description': 'Presence of patient self-reported fatigue after surgery.'}, {'measure': 'Postoperative thirst', 'timeFrame': '30 min after reversal', 'description': 'Presence of patient self-reported thirst after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plethysmographic variability index', 'PVI'], 'conditions': ['Anesthesia, General', 'Fluid Therapy', 'Ambulatory Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the intraoperative fluid administration. Low-risk patients that attend our day surgery unit, and who will be operated under general anesthesia, will be randomized to either a liberal fluid group, a restrictive fluid group or a dynamic monitoring group (PVI-directed). The amount of fluid infused together with the time to discharge, will be assessed in each participant during the postoperative period along with additional secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants attending the unit for a day surgery procedure\n* participants whose surgeries will be performed under general anesthesia\n* aged between 18-65 years\n* no abnormal findings on chest x-ray or electrocardiogram on preoperative evaluation\n* patients undergoing procedures which do not require opening of the abdominal or thoracic cavities\n\nExclusion Criteria:\n\n* ASA score III or higher\n* patients undergoing surgeries which require additional pain management procedures (e.g. selective nerve blockade, epidural anesthesia, etc.)\n* known pregnant women\n* known kidney disease (or serum creatinine \\>1.8 mg/dl)\n* known liver disease (or AST/ALT \\>60 U/l)\n* known chronic heart failure (determined by a LVEF \\<55%)\n* participants who develop hypotension intraoperatively and do not respond to 4 fluid challenges (1000 ml), requiring aggressive fluid resuscitation OR vasopressors\n* estimated blood loss during surgery \\>250 ml\n* development of an adverse reaction to any of the drugs administered during surgery (requiring additional medical management)'}, 'identificationModule': {'nctId': 'NCT03193320', 'acronym': 'MIFAS', 'briefTitle': 'Management of Intraoperative Fluids in Ambulatory Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Policlinica Metropolitana'}, 'officialTitle': 'Intraoperative Fluid Therapy Management in Low-risk Patients Under General Anesthesia- a Randomized Controlled Trial Comparing Liberal, Restrictive and Pleth Variability Index (PVI)-Guided Fluid Administration in a Day Surgery Setting', 'orgStudyIdInfo': {'id': '1701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal group protocol', 'description': 'Fluid loading with 500 ml at induction. Baseline fluid infusion - 8 ml/kg/h. Fluid challenge - if mean arterial pressure (MAP) falls to \\< 65 mmHg, a fluid challenge will be administered.', 'interventionNames': ['Other: Fluid therapy protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restrictive group protocol', 'description': 'No fluid loading at induction. Baseline fluid infusion - 4 ml/kg/h. Fluid challenges - if mean arterial pressure (MAP) falls to \\< 65 mmHg, a fluid challenge will be administered.', 'interventionNames': ['Other: Fluid therapy protocol']}, {'type': 'EXPERIMENTAL', 'label': 'PVI-guided group protocol', 'description': 'No fluid loading at induction. Baseline fluid infusion - 2 ml/kg/h. PVI will be monitored continuously since anesthesia induction. Fluid challenges - if PVI rises \\>=13 (or MAP falls \\< 65 mmHg), a fluid challenge will be administered.', 'interventionNames': ['Other: Fluid therapy protocol']}], 'interventions': [{'name': 'Fluid therapy protocol', 'type': 'OTHER', 'description': 'Only ringer lactate (RL solution will be used). 1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups. 2. Base infusion rate varies according to group. 3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes. Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded.', 'armGroupLabels': ['Liberal group protocol', 'PVI-guided group protocol', 'Restrictive group protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01061', 'city': 'Caracas', 'state': 'Miranda', 'country': 'Venezuela', 'contacts': [{'name': 'Telephone central', 'role': 'CONTACT', 'phone': '+582129080100'}, {'name': 'Pascual M Carucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Renzo G Di Natale, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Policlinica Metropolitana'}], 'centralContacts': [{'name': 'Renzo G Di Natale, MD', 'role': 'CONTACT', 'email': 'renzogdg@gmail.com', 'phone': '+584122715908'}], 'overallOfficials': [{'name': 'Pascual M Carucci, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Policlinica Metropolitana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinica Metropolitana', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor (MD)', 'investigatorFullName': 'Renzo Di Natale', 'investigatorAffiliation': 'Policlinica Metropolitana'}}}}