Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-05 @ 10:25 PM
Study NCT ID:
NCT03288051
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2017-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Free Flaps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D004280', 'term': 'Dobutamine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'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': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Pulse pressure variation during the operation and the post-operative 24 hours', 'timeFrame': '24 hours'}, {'measure': 'Assesment of free falp microcirculation by laser dopler flowmetry method.', 'timeFrame': '24 hours'}, {'measure': 'Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.', 'timeFrame': '24 hours'}, {'measure': 'Changes of Cardiac Index during the operation and the post-operative 24 hours.', 'timeFrame': '24 hours'}, {'measure': 'Mean arterial pressure during the operation and the post-operative 24 hours.', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Length of Intensive Care Unit stay', 'timeFrame': '24 hours'}, {'measure': 'Number of surgical or non-surgical complications.', 'timeFrame': '24 hours'}, {'measure': 'Length of Hospital stay', 'timeFrame': '10 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Optimal Tissue Perfusion']}, 'referencesModule': {'references': [{'pmid': '24010849', 'type': 'BACKGROUND', 'citation': 'Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.'}, {'pmid': '19944567', 'type': 'BACKGROUND', 'citation': 'Holzle F, Rau A, Loeffelbein DJ, Mucke T, Kesting MR, Wolff KD. Results of monitoring fasciocutaneous, myocutaneous, osteocutaneous and perforator flaps: 4-year experience with 166 cases. Int J Oral Maxillofac Surg. 2010 Jan;39(1):21-8. doi: 10.1016/j.ijom.2009.10.012. Epub 2009 Nov 26.'}, {'pmid': '26162676', 'type': 'BACKGROUND', 'citation': 'Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.'}, {'pmid': '31157652', 'type': 'DERIVED', 'citation': 'Laszlo I, Janovszky A, Lovas A, Vargan V, Oveges N, Tanczos T, Mikor A, Trasy D, Loderer Z, Piffko J, Szabo A, Molnar Z. Effects of goal-directed crystalloid vs. colloid fluid therapy on microcirculation during free flap surgery: A randomised clinical trial. Eur J Anaesthesiol. 2019 Aug;36(8):592-604. doi: 10.1097/EJA.0000000000001024.'}]}, 'descriptionModule': {'briefSummary': 'Maintaining satisfactory tissue perfusion is an essential of success during reconstructive free flap surgery following malign oral cavity tumours. Intra- and postoperative goal-directed fluid therapy is an appropriate tool for that. Continuous cardiac output monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary) might be superior to conventional, central venous and arterial pressure monitoring in terms of morbidity, complications, optimal fluid balance and days spent in hospital. However, there is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on microcirculation of free flaps implanted in the oral cavity during the post-operative period. The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring based, goal-directed fluid therapy on microcirculation of forearm flaps during the perioperative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18\n* Tumour location: intraoral\n* Free flap type: radial forearm\n* Signed informed concent form\n\nExclusion Criteria:\n\n* Vulnerable subject as defined in International Standards Organization 14155:2011\n* End stage oral cancer'}, 'identificationModule': {'nctId': 'NCT03288051', 'briefTitle': 'Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Free Flaps', 'organization': {'class': 'OTHER', 'fullName': 'Szeged University'}, 'officialTitle': 'Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Microcirculation in Free Flap Reconstruction of Intraoral Tumours.', 'orgStudyIdInfo': {'id': 'Free Flap Microcirculation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Crystalloid group', 'interventionNames': ['Other: Fluid management', 'Drug: Norepinephrine', 'Drug: Dobutamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colloid group', 'interventionNames': ['Other: Fluid management', 'Drug: Norepinephrine', 'Drug: Dobutamine']}], 'interventions': [{'name': 'Fluid management', 'type': 'OTHER', 'description': 'Primary fluid admission: 1 mL/bodyweight kg/ hour crystalloid. If Pulse pressure variation is lower than 10%; 250 mL/15 min of colloid or crystalloid is administered depending on randomization.', 'armGroupLabels': ['Colloid group', 'Crystalloid group']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'description': 'Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg. Mean arterial pressure must be maintained above 65 mmHg. Norepinephrine is titrated accordingly.', 'armGroupLabels': ['Colloid group', 'Crystalloid group']}, {'name': 'Dobutamine', 'type': 'DRUG', 'description': 'Dobutamine is administered if Cardiac index drops below 2.5 L/min/m2. Cardiac index must be maintained above 2.5 L/min/m2. Dobutamine is titrated accordingly.', 'armGroupLabels': ['Colloid group', 'Crystalloid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6725', 'city': 'Szeged', 'state': 'Csongrád megye', 'country': 'Hungary', 'facility': 'Department of Anaesthesiology and Intensive Therapy', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szeged University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Oral and Maxillofacial Surgery, University of Szeged', 'class': 'UNKNOWN'}, {'name': 'Institute of Surgical Research, University of Szeged', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of department', 'investigatorFullName': 'Zsolt Molnár, MD, PhD, DEAA', 'investigatorAffiliation': 'Szeged University'}}}}