Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT00799916
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2008-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'C485123', 'term': 'HES 130-0.4'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2008-11-28', 'studyFirstSubmitQcDate': '2008-11-28', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sublingual microcirculation', 'timeFrame': '24 hour'}], 'secondaryOutcomes': [{'measure': 'Gases, hemoglobin and oxygen saturations', 'timeFrame': '24 hours'}, {'measure': 'Electrolytes and lactate', 'timeFrame': '24 hours'}, {'measure': 'Anion gap corrected to albumin', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Fluid resuscitation', 'Voluven', 'Colloids', 'Saline solution', 'Crystalloids', 'Sublingual microcirculation'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '20813485', 'type': 'DERIVED', 'citation': 'Dubin A, Pozo MO, Casabella CA, Murias G, Palizas F Jr, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Comparison of 6% hydroxyethyl starch 130/0.4 and saline solution for resuscitation of the microcirculation during the early goal-directed therapy of septic patients. J Crit Care. 2010 Dec;25(4):659.e1-8. doi: 10.1016/j.jcrc.2010.04.007. Epub 2010 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'Fluid resuscitation of severe sepsis may consist of natural or artificial colloids or crystalloids. There is no evidence-based support for one type of fluid over another.\n\nThe investigators hypothesis is that fluid resuscitation with Voluven® is advantageous to normal saline solution to improve sublingual microcirculation.', 'detailedDescription': "Shock is the failure of circulatory system to maintain adequate cellular perfusion. Septic shock is primarily a form of distributive shock and is characterized by ineffective tissue oxygen delivery and extraction associated with inappropriate peripheral vasodilation despite preserved or increased cardiac output. In sepsis, a complex interaction between pathologic vasodilation, relative and absolute hypovolemia, myocardial dysfunction, and altered blood flow distribution occurs due to the inflammatory response to infection. Even after the restoration of intravascular volume, microcirculatory abnormalities may persist and lead to maldistribution of cardiac output.\n\nNotwithstanding the complexity of its pathophysiology and treatment, to maintain adequate organ perfusion is a main goal in the management of severe sepsis and septic shock. For this purpose, optimization of intravascular volume and preload is the more important step. Fluid challenge is a term used to describe the initial volume expansion period in which the response of the patient to fluid administration is carefully evaluated. During this process, large amounts of fluids may be administered over a short period of time under close monitoring to evaluate the patient's response and avoid the development of pulmonary edema. Fluid challenge should be given in all patients suspected of hypovolemia. Fluid resuscitation may consist of natural or artificial colloids or crystalloids. There is no evidence-based support for one type of fluid over another. As the volume of distribution is much larger for crystalloids than for colloids, resuscitation with crystalloids requires more fluid to achieve the same end points and might result in more edema. In addition, post-hoc analysis and experimental studies suggest that colloids might be superior to crystalloids, in terms of physiologic end-points, recruitment of the microcirculation and mortality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe sepsis\n\nExclusion Criteria:\n\n* Age of less than 18 years\n* Pregnancy, or the presence of an acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics\n* Cardiac dysrhythmias (as a primary diagnosis), contraindication to central venous catheterization, active gastrointestinal hemorrhage, seizure\n* Drug overdose, burn injury, trauma, a requirement for immediate surgery, uncured cancer (during chemotherapy\n* Immunosuppression (because of organ transplantation or systemic disease), do-not-resuscitate status, advanced directives restricting implementation of the protocol\n* Delayed admission to ICU from emergency department (more than 4 hours), or fluid resuscitation previous to ICU with more than 1,500 cc'}, 'identificationModule': {'nctId': 'NCT00799916', 'briefTitle': 'Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional de La Plata'}, 'officialTitle': 'Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis', 'orgStudyIdInfo': {'id': 'GEM 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Voluven', 'description': 'Resuscitation fluid: Voluven (R)', 'interventionNames': ['Drug: Resuscitation (Voluven)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline', 'description': 'Resuscitation fluid: Saline solution', 'interventionNames': ['Drug: Resuscitation (Saline)']}], 'interventions': [{'name': 'Resuscitation (Voluven)', 'type': 'DRUG', 'description': 'Resuscitation aimed at venous oxygen saturation higher than 70%', 'armGroupLabels': ['Voluven']}, {'name': 'Resuscitation (Saline)', 'type': 'DRUG', 'description': 'Resuscitation aimed at venous oxygen saturation higher than 70%', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1425', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clinica Bazterrica', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1425', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clínica Santa Isabel', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1425', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanatorio Otamendi y Miroli', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Arnaldo Dubin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanatorio Otamendi y Miroli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional de La Plata', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clínica Bazterrica', 'class': 'OTHER'}, {'name': 'Sanatorio Otamendi y Miroli', 'class': 'UNKNOWN'}, {'name': 'National Agency for Scientific and Technological Promotion, Argentina', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Analía Pérez/Dirección de evaluación de medicamentos', 'oldOrganization': 'Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)'}}}}