Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT00962156
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2009-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Scandinavian Starch for Severe Sepsis/Septic Shock Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D012769', 'term': 'Shock'}], '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': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}, {'id': 'C574052', 'term': 'LHFPL6 protein, human'}, {'id': 'C555762', 'term': 'Ringerfundin'}, {'id': 'C052337', 'term': 'sterofundin'}], '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 804}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-09', 'studyFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality or dialysis-dependency', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28 days'}, {'measure': 'Mortality', 'timeFrame': '6 months'}, {'measure': 'Mortality', 'timeFrame': '1 year'}, {'measure': 'Severity organ failure assessment score', 'timeFrame': 'Day 5', 'description': 'Excluding Glascow coma score'}, {'measure': 'Days free of ventilation', 'timeFrame': '90 days', 'description': 'Among survivors'}, {'measure': 'Days free of dialysis', 'timeFrame': '90 days', 'description': 'Among survivors'}, {'measure': 'Serious adverse reactions', 'timeFrame': 'Followed up until ICU discharge; consequently the time frame will vary among patients', 'description': 'Severe bleeding or severe allergic reactions'}, {'measure': 'Need of dialysis/haemofiltration', 'timeFrame': 'Within 90 days'}, {'measure': 'Need of ventilation', 'timeFrame': 'Within 90 days'}, {'measure': 'Kidney failure', 'timeFrame': 'Followed up until ICU discharge; consequently the time frame will vary among patients', 'description': 'Severity organ failure assessment score \\> 2 in the renal component'}, {'measure': 'Hospital length of stay', 'timeFrame': '90 days'}, {'measure': 'Coagulation analyses', 'timeFrame': '5 days', 'description': 'At selected hospitals whole-blood and biochemical coagulation analyses constitute additional secondary endpoints'}, {'measure': 'NGAL', 'timeFrame': '5 days', 'description': 'At selected trial sites will plasma and urinary NGAL be analysed at randomisation to assess the predictive value for dialyse and kidney failure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sepsis', 'Shock', 'Fluid therapy', 'Plasma expanders'], 'conditions': ['Severe Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '21269526', 'type': 'BACKGROUND', 'citation': 'Perner A, Haase N, Wetterslev J, Aneman A, Tenhunen J, Guttormsen AB, Klemenzson G, Pott F, Bodker KD, Badstolokken PM, Bendtsen A, Soe-Jensen P, Tousi H, Bestle M, Pawlowicz M, Winding R, Bulow HH, Kancir C, Steensen M, Nielsen J, Fogh B, Madsen KR, Larsen NH, Carlsson M, Wiis J, Petersen JA, Iversen S, Schoidt O, Leivdal S, Berezowicz P, Pettila V, Ruokonen E, Klepstad P, Karlsson S, Kaukonen M, Rutanen J, Karason S, Kjaeldgaard AL, Holst LB, Wernerman J; Scandinavian Critical Care Trials Group. Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S--Scandinavian Starch for Severe Sepsis/Septic Shock trial): study protocol, design and rationale for a double-blinded, randomised clinical trial. Trials. 2011 Jan 27;12:24. doi: 10.1186/1745-6215-12-24.'}, {'pmid': '22738085', 'type': 'RESULT', 'citation': "Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27."}, {'pmid': '25907781', 'type': 'DERIVED', 'citation': 'Ostrowski SR, Haase N, Muller RB, Moller MH, Pott FC, Perner A, Johansson PI. Association between biomarkers of endothelial injury and hypocoagulability in patients with severe sepsis: a prospective study. Crit Care. 2015 Apr 24;19(1):191. doi: 10.1186/s13054-015-0918-5.'}, {'pmid': '24807084', 'type': 'DERIVED', 'citation': "Perner A, Haase N, Winkel P, Guttormsen AB, Tenhunen J, Klemenzson G, Muller RG, Aneman A, Wetterslev J. Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer's acetate. Intensive Care Med. 2014 Jul;40(7):927-34. doi: 10.1007/s00134-014-3311-y. Epub 2014 May 8."}, {'pmid': '24037226', 'type': 'DERIVED', 'citation': 'Muller RG, Haase N, Wetterslev J, Perner A. Effects of hydroxyethyl starch in subgroups of patients with severe sepsis: exploratory post-hoc analyses of a randomised trial. Intensive Care Med. 2013 Nov;39(11):1963-71. doi: 10.1007/s00134-013-3090-x. Epub 2013 Sep 14.'}], 'seeAlsoLinks': [{'url': 'http://ssai.info/news/6s-trial-analysis-plan.html', 'label': 'Statistical analysis plan for the 6S trial'}]}, 'descriptionModule': {'briefSummary': '* By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill.\n* High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis.\n* Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.\n* HES 130/0.4 is largely unstudied in ICU patients.\n* This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis.\n* The trial will provide important data to all clinicians who resuscitate septic patients.', 'detailedDescription': 'Fluid is the mainstay treatment in sepsis resuscitation, but the effects of different crystalloid and colloid solutions on outcome remain unknown.\n\nPreviously, a high molecular weight hydroxyethyl starch, HES 200, was used, but this was found to cause acute kidney failure in patients with severe sepsis. As kidney failure is an independent risk factor for death in these patients, HES 200 is not used anymore. In stead a lower molecular weight starch, HES 130, has been developed. Presently, this is the preferred colloid in Scandinavian intensive care units (ICU), but the effects of HES 130 in ICU patients are currently unknown. The proposed Scandinavian multicentre study will be conducted to assess if HES 130 contributes to acute kidney failure in patients with severe sepsis. As HES 130 is widely used, the trial will provide important safety data to clinicians who resuscitate septic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll adult patients who\n\n* Undergo resuscitation in the ICU\n* AND fulfillment within the previous 24 hours of the criteria for severe sepsis (SCCM/ACCP)\n* AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)\n\nExclusion Criteria:\n\nThe following patients will not be evaluated for inclusion:\n\n* Age \\< 18 years old\n* Previously randomised in the 6S trial\n* Allergy towards hydroxyethyl starch or malic acid\n* Treatment with \\> 1000 ml's of any synthetic colloid within the last 24 hours prior to randomisation\n* Any form of renal replacement therapy\n* Acute burn injury \\> 10% body surface area\n* Severe hyperkalaemia, p-K \\> 6 mM\n* Liver or kidney transplantation during current hospital admission\n* Intracranial bleeding within current hospitalisation\n* Enrollment into another ICU trial of drugs with potential action on circulation, renal function or coagulation\n* Withdrawal of active therapy"}, 'identificationModule': {'nctId': 'NCT00962156', 'acronym': '6S', 'briefTitle': 'Scandinavian Starch for Severe Sepsis/Septic Shock Trial', 'organization': {'class': 'OTHER', 'fullName': 'Scandinavian Critical Care Trials Group'}, 'officialTitle': 'Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis', 'orgStudyIdInfo': {'id': '2008-262'}, 'secondaryIdInfos': [{'id': 'EudraCT no. 2009-010104-28'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HES 130/0.4', 'description': 'Volume expansion', 'interventionNames': ['Drug: 6% Hydroxyethyl starch 130/0.4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ringer acetate', 'description': 'Volume expansion', 'interventionNames': ['Drug: Ringers acetate']}], 'interventions': [{'name': '6% Hydroxyethyl starch 130/0.4', 'type': 'DRUG', 'otherNames': ['6% Tetraspan'], 'description': 'Infusion for volume expansion in the ICU', 'armGroupLabels': ['HES 130/0.4']}, {'name': 'Ringers acetate', 'type': 'DRUG', 'otherNames': ['Ringerfundin / Sterofundin'], 'description': 'Infusion for volume expansion in the ICU', 'armGroupLabels': ['Ringer acetate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Gentofte Hosptial', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Glostrup Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Esbjerg Hospital', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'city': 'Herning', 'country': 'Denmark', 'facility': 'Herning Hospital', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Hillerød Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'city': 'Hjørring', 'country': 'Denmark', 'facility': 'Hjørring Hospital', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}, {'city': 'Holbæk', 'country': 'Denmark', 'facility': 'Holbæk Hospital', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Holstebro Hospital', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}, {'city': 'Køge', 'country': 'Denmark', 'facility': 'Køge Hospital', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'city': 'Næstved', 'country': 'Denmark', 'facility': 'Næstved Hospital', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Slagelse', 'country': 'Denmark', 'facility': 'Slagelse Hospital', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}, {'city': 'Sønderborg', 'country': 'Denmark', 'facility': 'Sønderborg Hospital', 'geoPoint': {'lat': 54.90896, 'lon': 9.78917}}, {'city': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Dept of Intensive Care, Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Kuopio', 'country': 'Finland', 'facility': 'Dept. of Intensive Care, Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Dept of Intensive Care, Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Reykjavik', 'country': 'Iceland', 'facility': 'Dept. of Intensive Care, Landspitali', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}, {'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Stavanger', 'country': 'Norway', 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'city': 'Tromsø', 'country': 'Norway', 'facility': 'Intensive Care Unit, University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital, Trondheim University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Anders Perner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICU, Rigshospitalet, University of Copenhagen'}, {'name': 'Nicolai Haase, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anders Perner', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Copenhagen Trial Unit, Center for Clinical Intervention Research', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chairman', 'investigatorFullName': 'Anders Perner', 'investigatorAffiliation': 'Scandinavian Critical Care Trials Group'}}}}