Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT01443494
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2011-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High MAP in Septic Shock With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'xujingyuanmail@163.com', 'phone': '86-025-83262550', 'title': 'Jingyuan Xu', 'organization': 'Intensive Care Unit, Zhongda Hospital, Southeast University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Firstly, cardiac output was monitored by NICOM system to minimize the invasive operation.\n\nSecondly, the number of patients enrolled in the study was relatively small. Next, immediate changes of the increase in MAP were investigated.'}}, 'adverseEventsModule': {'timeFrame': 'During the study procedure for about 2 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Septic Shock Patients Despite EGDT', 'description': 'Patients requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Arterial Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Septic Shock Patients Despite EGDT', 'description': 'After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Target MAP stabilization for 30 min', 'description': "As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients' physical examination records of the last two years was registered and assumed as patients' usual level of MAP and target MAP. If patients' medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed.\n\nAfter stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perfused Vessel Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Septic Shock Patients Despite EGDT', 'description': 'After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.08', 'spread': '2.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Target MAP stabilization for 30 min', 'description': 'Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density', 'unitOfMeasure': 'vessels/mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Septic Shock Patients Despite EGDT With Hypertension', 'description': 'Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Septic Shock Patients Despite EGDT With Hypertension', 'description': 'Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Detailed enquiry about the target MAP to their next kin was performed in all of the patients.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2011-09-28', 'resultsFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2011-09-28', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-06-13', 'studyFirstPostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Arterial Pressure', 'timeFrame': 'Target MAP stabilization for 30 min', 'description': "As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients' physical examination records of the last two years was registered and assumed as patients' usual level of MAP and target MAP. If patients' medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed.\n\nAfter stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements."}], 'secondaryOutcomes': [{'measure': 'Perfused Vessel Density', 'timeFrame': 'Target MAP stabilization for 30 min', 'description': 'Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['septic shock', 'microcirculation', 'norepinephrine', 'fluid'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '15343008', 'type': 'BACKGROUND', 'citation': 'Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. doi: 10.1097/01.ccm.0000138558.16257.3f.'}, {'pmid': '23363690', 'type': 'BACKGROUND', 'citation': 'Correa TD, Vuda M, Takala J, Djafarzadeh S, Silva E, Jakob SM. Increasing mean arterial blood pressure in sepsis: effects on fluid balance, vasopressor load and renal function. Crit Care. 2013 Jan 30;17(1):R21. doi: 10.1186/cc12495.'}, {'pmid': '23534963', 'type': 'BACKGROUND', 'citation': 'Beloncle F, Lerolle N, Radermacher P, Asfar P. Target blood pressure in sepsis: between a rock and a hard place. Crit Care. 2013 Mar 26;17(2):126. doi: 10.1186/cc12543.'}, {'pmid': '17584921', 'type': 'BACKGROUND', 'citation': 'Sevransky JE, Nour S, Susla GM, Needham DM, Hollenberg S, Pronovost P. Hemodynamic goals in randomized clinical trials in patients with sepsis: a systematic review of the literature. Crit Care. 2007;11(3):R67. doi: 10.1186/cc5948.'}, {'pmid': '10966242', 'type': 'BACKGROUND', 'citation': 'LeDoux D, Astiz ME, Carpati CM, Rackow EC. Effects of perfusion pressure on tissue perfusion in septic shock. Crit Care Med. 2000 Aug;28(8):2729-32. doi: 10.1097/00003246-200008000-00007.'}, {'pmid': '19384212', 'type': 'BACKGROUND', 'citation': 'Jhanji S, Stirling S, Patel N, Hinds CJ, Pearse RM. The effect of increasing doses of norepinephrine on tissue oxygenation and microvascular flow in patients with septic shock. Crit Care Med. 2009 Jun;37(6):1961-6. doi: 10.1097/CCM.0b013e3181a00a1c.'}, {'pmid': '19534818', 'type': 'BACKGROUND', 'citation': 'Dubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17.'}, {'pmid': '21936903', 'type': 'BACKGROUND', 'citation': 'Thooft A, Favory R, Salgado DR, Taccone FS, Donadello K, De Backer D, Creteur J, Vincent JL. Effects of changes in arterial pressure on organ perfusion during septic shock. Crit Care. 2011;15(5):R222. doi: 10.1186/cc10462. Epub 2011 Sep 21.'}, {'pmid': '25887027', 'type': 'DERIVED', 'citation': 'Xu JY, Ma SQ, Pan C, He HL, Cai SX, Hu SL, Liu AR, Liu L, Huang YZ, Guo FM, Yang Y, Qiu HB. A high mean arterial pressure target is associated with improved microcirculation in septic shock patients with previous hypertension: a prospective open label study. Crit Care. 2015 Mar 30;19(1):130. doi: 10.1186/s13054-015-0866-0.'}]}, 'descriptionModule': {'briefSummary': "We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.", 'detailedDescription': "The effect of mean arterial pressure (MAP) titration to higher level on microcirculation in septic shock patients with previous hypertension remains unknown. Our goal was to assess the effect of MAP titration to patients' usual level on microcirculation in septic shock patients with previous hypertension. We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with septic shock for less than 24 hours\n* Fluid resuscitation was performed according to the guideline for treating septic shock to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous oxygen saturation for more than 70%\n* Patients requiring norepinephrine (NE) to maintain a MAP of 65 mm Hg. Septic shock patients with fluid resuscitation after CVP \\> 8mmHg and mean blood pressure \\> 65 mmHg\n\nExclusion Criteria:\n\n* Pregnancy\n* Age \\< 18 years\n* Inability to acquire the usual level of MAP\n* Refusal of consent by the patient or relative\n* Participation in other trials during the last three months\n* Hypertensive patients without hypertension treatment'}, 'identificationModule': {'nctId': 'NCT01443494', 'briefTitle': 'High MAP in Septic Shock With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'High Mean Arterial Pressure Target Improves Microcirculation in Septic Shock Patients With Previous Hypertension', 'orgStudyIdInfo': {'id': 'SoutheastUChina2011ZDllKY03.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NE group', 'description': 'Adjust NE dose to titrate MAP to usual level regardless of fluid responsiveness when after EGDT.', 'interventionNames': ['Other: NE']}], 'interventions': [{'name': 'NE', 'type': 'OTHER', 'description': 'norepinephine', 'armGroupLabels': ['NE group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Haibo Qiu, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Southeast University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ZhongDa Hospital', 'investigatorFullName': 'Jingyuan,Xu', 'investigatorAffiliation': 'Southeast University, China'}}}}