Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT00882427
Status:
COMPLETED
Last Update Posted:
2010-02-05
First Post:
2009-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-04', 'studyFirstSubmitDate': '2009-04-15', 'studyFirstSubmitQcDate': '2009-04-15', 'lastUpdatePostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of time within the predefined glucose target range of 80-150 mg/dL', 'timeFrame': 'from start of treatment to the last glucose measurement under treatment'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemias', 'timeFrame': 'from start of treatment to the last glucose measurement under treatment'}, {'measure': 'Usability parameters like convenience of alarming function; workload; blood sampling frequency', 'timeFrame': 'from start of treatment to the last glucose measurement under treatment'}, {'measure': 'Concomitant medication including insulin infusion rate, parenteral/enteral nutrition', 'timeFrame': 'from start of treatment to the last glucose measurement under treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['algorithm', 'tight glycemic control', 'glucose control', 'intensive care', 'insulin', 'ICU'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '18661120', 'type': 'BACKGROUND', 'citation': 'Cordingley JJ, Vlasselaers D, Dormand NC, Wouters PJ, Squire SD, Chassin LJ, Wilinska ME, Morgan CJ, Hovorka R, Van den Berghe G. Intensive insulin therapy: enhanced Model Predictive Control algorithm versus standard care. Intensive Care Med. 2009 Jan;35(1):123-8. doi: 10.1007/s00134-008-1236-z. Epub 2008 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients. Based on this emerging clinical evidence, there are increasing efforts worldwide to maintain strict glycaemic control in critically ill patients. However, achieving this goal requires extensive nursing efforts, including frequent bedside glucose monitoring and the implementation of complex intensive insulin infusion protocols. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. This study will investigate the performance of an eMPC algorithm adjusted to target the range 4.4 - 8.3 mmol/L in line with the Surviving Sepsis guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: \\> 18 years of age\n* Admitted following cardiac surgery\n* Stay in the ICU expected to be \\> 20h\n* Blood glucose \\> 6.7 mmol/l within 4 hours of admission to intensive care or patient already receiving insulin treatment\n\nExclusion Criteria:\n\n* Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.\n* Known or suspected allergy to insulin\n* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e. liver failure, other fatal organ failures)\n* Patients participating in another study\n* Moribund patients likely to die within 24 hours\n* Patients after organ transplantation within the last three months\n* Patients under high dose cortisol treatment (cortisol \\> 1000 mg/day or equivalent doses of hydrocortisol)'}, 'identificationModule': {'nctId': 'NCT00882427', 'acronym': 'Aldea_02', 'briefTitle': 'Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Single-center, Open Study on the Performance of the Software eMPC Algorithm Used for Blood Glucose Control Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the Intensive Care Unit', 'orgStudyIdInfo': {'id': 'HC-G-H-0807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eMPC', 'description': 'improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients', 'interventionNames': ['Other: enhanced model predictive control algorithm (eMPC)']}], 'interventions': [{'name': 'enhanced model predictive control algorithm (eMPC)', 'type': 'OTHER', 'description': 'eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control', 'armGroupLabels': ['eMPC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital and Harefield NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jeremy Cordingley, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Brompton & Harefield NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Norman Kachel', 'oldOrganization': 'B. Braun Melsungen AG'}}}}