Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-03 @ 6:48 AM
Study NCT ID:
NCT01811966
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2013-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Volume Substitution in Elective Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2013-03-13', 'studyFirstSubmitQcDate': '2013-03-14', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemodynamic instability', 'timeFrame': 'at time of introduction of anesthesia', 'description': 'Hemodynamic instability during induction of anesthesia (0-10 min), defined as at least one of the following:\n\n* Systolic blood pressure \\< 80 mmHg or decrease of 20% in preexistent hypertension\n* Mean blood pressure \\< 50 mmHg or decrease of 20% or \\> 20 mmHg in preexistent hypertension\n* Bradycardia \\< 45/min or decrease of 20% in preexistent bradycardia \\< 60/min.\n* Tachycardia \\> 120/min\n* Cardiac index \\< 2.0 l/min/m²'}], 'secondaryOutcomes': [{'measure': 'Stroke volume index > 35 ml/m2', 'timeFrame': 'at time of anesthesia'}, {'measure': 'Stroke volume variation < 12 %', 'timeFrame': 'at time of anesthesia'}, {'measure': 'Enddiastolic area (EDA) > 10 cm2', 'timeFrame': 'at time of anesthesia', 'description': 'transthoracic echocardiographic parasternal short axis enddiastolic area'}, {'measure': 'inferior vana cava diameter (VCI) > 15 mm', 'timeFrame': 'at time of anesthesia', 'description': 'transthoracic echocardiographic inferior vena cava diameter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preoperative volume substitution', 'hypovolemia', 'preoperative fasting'], 'conditions': ['Hemodynamic Instability', 'Hypovolemia', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during introduction of anesthesia.\n\nThe purpose of this study is to test the hypothesis that a defined preoperative volume substitution compared to standard procedure will result in a reduced incidence of hemodynamic instabilities during introduction of anesthesia in elective surgery patients.', 'detailedDescription': 'The preoperative fasting period often lasts longer than 2 hours as recommended by various national and international anesthetic guidelines. Thus, hypovolemia is more often then anticipated. In awake patients this condition is often masked. Introduction of anesthesia often leads to an unmasking of hypovolemia with a consecutive hemodynamic instability.\n\nAim of the study is to test the hypothesis that a preoperative volume substitution (8 ml/kg RingerAcetate Solution in 15 min. prior to introduction of anesthesia) reduces possible hemodynamic instabilities during initiation of anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* thyreoid, parathyroid or gallbladder surgery\n* general anesthesia\n\nExclusion Criteria:\n\n* coronary artery disease\n* congestive heart disease (≥ New York Heart Association (NYHA) 2)\n* insulin dependent diabetes mellitus\n* renal insufficiency (creatinine \\> 2,0 mg/dl)\n* cerebrovascular disease\n* severe hypertension (≥ antihypertensive drugs)'}, 'identificationModule': {'nctId': 'NCT01811966', 'briefTitle': 'Preoperative Volume Substitution in Elective Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Philipps University Marburg'}, 'officialTitle': 'Preoperative Volume Substitution in Fasting Patients Undergoing Elective Surgery - Impact on Hemodynamic Stability During Anesthesia', 'orgStudyIdInfo': {'id': 'UKGMVolume'}, 'secondaryIdInfos': [{'id': 'UKGMVolume', 'type': 'OTHER', 'domain': 'University Hospital of Marburg'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'preoperative none substitution of i.v. fluids.', 'interventionNames': ['Other: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Volume', 'description': 'preoperative substitution of a defined amount of i.v. fluids (8 ml/kg RingerAcetate solution for 15 min prior to introduction of anesthesia).', 'interventionNames': ['Other: Volume']}], 'interventions': [{'name': 'Volume', 'type': 'OTHER', 'otherNames': ['RingerAcetate Solution', 'cristalloide'], 'armGroupLabels': ['Volume']}, {'name': 'Control', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-35033', 'city': 'Marburg', 'country': 'Germany', 'facility': 'University Hospital of Marburg, Department of Anesthesia', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'overallOfficials': [{'name': 'Thomas Kratz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philipps University Marburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Thomas Kratz', 'investigatorFullName': 'Dr. Thomas Kratz', 'investigatorAffiliation': 'Philipps University Marburg'}}}}