Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-28 @ 1:17 PM
Study NCT ID:
NCT01194492
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2010-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Albumin Kinetics in Generalized Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2010-08-31', 'studyFirstSubmitQcDate': '2010-09-02', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in albumin transcapillary escape rate', 'timeFrame': '2 days', 'description': 'Transcapillary escape rate is measured as the rate of decrease of 125I-albumin in plasma over 90 min. The assessment is performed twice, immediately before surgery and in the second post-operative day, respectively.'}, {'measure': 'Change from baseline in albumin synthesis rate', 'timeFrame': '2 days'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, Blood leukocyte count, and P-CRP)', 'timeFrame': '2 days', 'description': 'The markers of inflammation is measured twice in each patient, immediately before and two days after surgery, respectively.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['plasma albumin', 'inflammatory reaction', 'systemic inflammatory response syndrome'], 'conditions': ['Major Abdominal Surgery']}, 'referencesModule': {'references': [{'pmid': '26313170', 'type': 'RESULT', 'citation': 'Norberg A, Rooyackers O, Segersvard R, Wernerman J. Albumin Kinetics in Patients Undergoing Major Abdominal Surgery. PLoS One. 2015 Aug 27;10(8):e0136371. doi: 10.1371/journal.pone.0136371. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the kinetics of endogenous albumin is altered by the generalized inflammation caused by major abdominal surgery.', 'detailedDescription': 'Albumin infusions have been used for expansion of the plasma volume for more than 60 years, not only in the operating room, but also in trauma and sepsis. However, there is an ongoing debate whether albumin is good or bad for the patient compared to other intravenous fluids, in different situations. Our research program aims at exploring this issue, starting by describing how the body handles the endogenous albumin in connection with severe inflammation. The final goal is to improve fluid treatment for these patients.\n\nPlasma albumin is often decreased in inflammation. However, the underlying mechanisms are not well described. Two aspects of albumin kinetics will be covered in this study by measurements immediately before and two days after major abdominal surgery, that will serve as a model for generalized inflammation. Albumin fractional synthesis rate will be determined by the incorporation of deuterium labelled phenylalanine into plasma albumin. Albumin distribution will be measured as transcapillary escape rate of radioiodinated albumin. By assessment of P-albumin and plasma volume it will be possible to calculate albumin absolute rate of synthesis and albumin absolute flux from the central compartment, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* patients planned for major abdominal surgery, pancreatic\n* age ≥ 40 years\n\nExclusion Criteria:\n\n* pregnant or lactating patients\n* planned peri-operative infusions of albumin or plasma\n* S-creatinine \\> 110 mmol/L\n* allergy against iodine\n* other conditions preventing the subject from participating in the study, as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT01194492', 'briefTitle': 'Albumin Kinetics in Generalized Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Albumin Kinetics in Generalized Inflammation - an Exploratory Study on Patients Before and After Major Abdominal Surgery', 'orgStudyIdInfo': {'id': '2010-018529-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Albumin kinetics', 'interventionNames': ['Radiation: Albumin transcapillary escape rate (125I-albumin)']}], 'interventions': [{'name': 'Albumin transcapillary escape rate (125I-albumin)', 'type': 'RADIATION', 'otherNames': ['SERALB-125'], 'description': 'Repeated measure by injection of 0.1 megabecquerel and 0.3 megabecquerel of 125-iodine labeled albumin before surgery and 2 days after surgery, respectively.', 'armGroupLabels': ['Albumin kinetics']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hosptial, Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Sigridur Kalman, MD, Ass Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet, Institution of Clinical Science Intervention and Technology, Dept of Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska University Hospital', 'class': 'OTHER'}, {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Ake Norberg', 'investigatorAffiliation': 'Karolinska Institutet'}}}}