Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-30 @ 10:35 AM
Study NCT ID:
NCT01301469
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2011-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of HES 130 in Balanced and in Unbalanced Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-02', 'studyFirstSubmitDate': '2011-02-11', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum difference of the mean arterial blood pressure', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Decreased and Nonspecific Blood Pressure Disorders and Shock']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Male or female (non pregnant) patients; between 18 and 70 years\n* Elective non-cardiac surgery (except pancreatic or neurological surgery) with an estimated operation duration of 2 hours or longer\n* General anesthesia\n* Voluntary consent\n\nExclusion:\n\n* Patients of ASA-class III or IV, Cardiac insufficiency NYHA classes III. IV\n* BMI \\< 18 or \\> 29\n* Patients with daily urine output \\< 1L\n* Patients on hemodialysis\n* Abnormal liver or renal function (i. e. above upper limit of normal range)\n* Abnormal coagulation function (prothrombin time (PT) 3 seconds higher than normal or activated partial thromboplastin time (APTT) 10 seconds higher than normal)\n* Hgb \\< 10g/dl or HCT \\< 30%\n* Potassium, sodium or chloride above the upper limit of normal of the laboratory\n* History of diabetes mellitus\n* Known history of a mental or neurological disorder, such as epileptic seizures.\n* History of hypertension and/or taking a beta-receptor blocker or history of atrial fibrillation\n* Patients with known hypersensitivity and with contraindications to HES or any of the excipients'}, 'identificationModule': {'nctId': 'NCT01301469', 'briefTitle': 'Comparison of HES 130 in Balanced and in Unbalanced Solution', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Prospective, Randomized, Double-blind, Controlled, Multicenter Study on the Efficacy and Safety of HES 130/0. 42 in a Balanced Electrolyte Solution vs a HES 130/0.4 in a Sodium Chloride Solution in Elective Surgery Patients', 'orgStudyIdInfo': {'id': 'HC-G-H-0801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': "6% HES 130/0.42 in plasma adapted Ringer's solution (balanced solution)", 'interventionNames': ["Drug: 6% HES 130/0.42 in plasma adapted Ringer's solution"]}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'HES 130/0.4 in a saline solution', 'interventionNames': ['Drug: 6% HES 130/0.4 in a saline solution']}], 'interventions': [{'name': "6% HES 130/0.42 in plasma adapted Ringer's solution", 'type': 'DRUG', 'description': "60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution)", 'armGroupLabels': ['1']}, {'name': '6% HES 130/0.4 in a saline solution', 'type': 'DRUG', 'description': '60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': '2 Hospitals', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Buwei Yu, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}