Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 12:52 PM
Study NCT ID:
NCT01337934
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2011-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactated Ringer Versus Albumin in Early Sepsis Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2011-04-13', 'studyFirstSubmitQcDate': '2011-04-15', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality in 7 days for any cause', 'timeFrame': 'day 7'}], 'secondaryOutcomes': [{'measure': 'Evaluation of sequential organ failure assessment (SOFA) score', 'timeFrame': 'from day 1 until day 7 of care in ICU'}, {'measure': 'ICU length of stay', 'timeFrame': 'day 28'}, {'measure': 'hospital length of stay', 'timeFrame': 'day 28'}, {'measure': 'ventilator-free days', 'timeFrame': 'day 28'}, {'measure': 'Needing of renal replacement therapy', 'timeFrame': 'day 28'}, {'measure': 'days free of vasopressor', 'timeFrame': 'day 28'}, {'measure': 'Mortality in 28-days', 'timeFrame': '28 days after randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Septic shock', 'Sepsis', 'Albumin', 'Lactated Ringer'], 'conditions': ['Septic Shock', 'Severe Sepsis']}, 'referencesModule': {'references': [{'pmid': '20940381', 'type': 'BACKGROUND', 'citation': 'Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.'}]}, 'descriptionModule': {'briefSummary': 'The use of albumin in critical ill patients is a matter of controversy. A large randomized controlled trial reported that albumin was as safe and effective as crystalloid solution for fluid replacement in intensive care unit, although the last one was less expensive. In Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids over colloids. But recently, a retrospective analysis of patients with severe sepsis from SAFE study reported that the use of albumin in these patients would be superior, regarding reduction of mortality. The aim of this study is determine whether the use of albumin improve clinical outcomes in patients with severe sepsis or septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal or higher than 18 years-old\n* Severe sepsis or septic shock into 6 hours of evolution\n* Written informed consent\n\nExclusion Criteria:\n\n* Shock from other causes\n* Adverse reactions to human albumin\n* Previous fluid resuscitation during current disease\n* Previous use of albumin in the last 72 hours\n* Religion objection\n* Enrollment in another study\n* Traumatic brain injury\n* Hepatic cirrhosis\n* End stage renal disease\n* Plasmapheresis\n* End of life patients'}, 'identificationModule': {'nctId': 'NCT01337934', 'acronym': 'RASP', 'briefTitle': 'Lactated Ringer Versus Albumin in Early Sepsis Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '360/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Lactated Ringer', 'description': 'Patients randomized for this group will receive 500 ml of lactated Ringer solution in early phase of sepsis or septic shock (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg, or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension.', 'interventionNames': ['Drug: Lactated Ringer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Albumin', 'description': 'Patients randomized for Albumin group will receive 500 ml of 4% Albumin solution in early phase of sepsis (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension.', 'interventionNames': ['Drug: Albumin']}], 'interventions': [{'name': 'Lactated Ringer', 'type': 'DRUG', 'description': 'Lactated Ringer', 'armGroupLabels': ['Lactated Ringer']}, {'name': 'Albumin', 'type': 'DRUG', 'description': 'Albumin 4%', 'armGroupLabels': ['Albumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246000', 'city': 'São Paulo', 'state': 'Sao Paulo/SP', 'country': 'Brazil', 'facility': 'Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Juliano A Almeida, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Ludhmila Hajjar, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Clarice H Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instituto do Cancer do Estado de Sao Paulo', 'investigatorFullName': 'Juliano P Almeida, MD, PhD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}