Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-02-22 @ 3:40 AM
Study NCT ID:
NCT01923961
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2013-08-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006435', 'term': 'Renal Dialysis'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'horstdieter.lemke@excorlab.de', 'phone': '+49-6022-812647', 'title': "'Dr. Horst-Dieter Lemke", 'organization': 'eXcorLab GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Hemodiafiltration, NaCl Infusion', 'description': '5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.\n\n5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hemodialysis', 'description': 'Standard bicarbonate high-flux hemodialysis', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Hemodiafiltration', 'description': 'Standard predilution Hemodiafiltration', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Removal of Para-cresylsulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodiafiltration, NaCl Infusion', 'description': '5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.\n\n5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma.'}, {'id': 'OG001', 'title': 'Hemodialysis', 'description': 'Standard bicarbonate high-flux hemodialysis'}, {'id': 'OG002', 'title': 'Hemodiafiltration', 'description': 'Standard predilution Hemodiafiltration'}], 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '32.6', 'spread': '18.5', 'groupId': 'OG001'}, {'value': '33.6', 'spread': '16.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'Determination of reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention', 'unitOfMeasure': 'percentage of reduction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'PRIMARY', 'title': 'Removal of Indoxylsulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodiafiltration, NaCl Infusion', 'description': '5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.\n\n5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma.'}, {'id': 'OG001', 'title': 'Hemodialysis', 'description': 'Standard bicarbonate high-flux hemodialysis'}, {'id': 'OG002', 'title': 'Hemodiafiltration', 'description': 'Standard predilution Hemodiafiltration'}], 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '30.9', 'spread': '23.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'Determination of the reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention', 'unitOfMeasure': 'percentage of reduction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Plasma Sodium Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodiafiltration, NaCl Infusion', 'description': '5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.\n\n5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma.'}, {'id': 'OG001', 'title': 'Hemodialysis', 'description': 'Standard bicarbonate high-flux hemodialysis'}, {'id': 'OG002', 'title': 'Hemodiafiltration', 'description': 'Standard predilution Hemodiafiltration'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'spread': '3', 'groupId': 'OG000'}, {'value': '133', 'spread': '2', 'groupId': 'OG001'}, {'value': '134', 'spread': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'Maximum arterial sodium concentrations', 'unitOfMeasure': 'mval/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Hemocompatibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodiafiltration, NaCl Infusion', 'description': '5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration.\n\n5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma.'}, {'id': 'OG001', 'title': 'Hemodialysis', 'description': 'Standard bicarbonate high-flux hemodialysis'}, {'id': 'OG002', 'title': 'Hemodiafiltration', 'description': 'Standard predilution Hemodiafiltration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction.', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HDF NaCl Infusion, Then HD, Then Standard Pre-HDF', 'description': 'Participants first received hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then received 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveived 4 hours of standard predilution hemodiafiltration.'}, {'id': 'FG001', 'title': 'HD, Then Standard Pre-HDF, Then HDF NaCl Infusion', 'description': 'Participants first received bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then received 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveived 4 hours of hemodiafiltration with infusion of 5 M NaCl.'}, {'id': 'FG002', 'title': 'Standard Pre-HDF, Then HDF NaCl Infusion, Then HD', 'description': 'Participants first received standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then received 4 hours of hemodiafiltration with infusion of 5 M NaCl. After another washout period of 1 week, they reveived 4 hours of bicarbonate hemodialysis.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'HDF NaCl, Then HD, Then Standard Pre-HDF', 'description': 'Participants first received hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then received 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveived 4 hours of standard predilution hemodiafiltration.'}, {'id': 'BG001', 'title': 'HD, Then Standard Pre-HDF, Then HDF NaCl', 'description': 'Participants first received bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then received 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveived 4 hours of hemodiafiltration with infusion of 5 M NaCl.'}, {'id': 'BG002', 'title': 'Standard Pre-HDF, Then HDF NaCl, Then HD', 'description': 'Participants first received standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then received 4 hours of hemodiafiltration with infusion of 5 M NaCl. After another washout period of 1 week, they reveived 4 hours of bicarbonate hemodialysis.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '78'}, {'value': '62', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '78'}, {'value': '62', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '78'}, {'value': '62', 'groupId': 'BG003', 'lowerLimit': '46', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sodium Chloride (NaCl) Infusion', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2013-08-10', 'resultsFirstSubmitDate': '2017-07-30', 'studyFirstSubmitQcDate': '2013-08-14', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-27', 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Removal of Para-cresylsulfate', 'timeFrame': '4 hours', 'description': 'Determination of reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention'}, {'measure': 'Removal of Indoxylsulfate', 'timeFrame': '4 hours', 'description': 'Determination of the reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention'}], 'secondaryOutcomes': [{'measure': 'Plasma Sodium Concentrations', 'timeFrame': '4 hours', 'description': 'Maximum arterial sodium concentrations'}, {'measure': 'Hemocompatibility', 'timeFrame': '4 hours', 'description': 'Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Maintenance hemodialysis or hemodiafiltration', '>18 years', 'Stable condition'], 'conditions': ['End-stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'An increase of the free fraction may allow a better removal of of protein-bound uremic toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl) concentration will be increased in the infusion fluid at a target NaCl concentration and the effect on the removal of protein-bound toxins will be determined. Comparisons will be made to standard hemodialysis and hemodiafiltration.', 'detailedDescription': "Eight maintenance dialysis patients will be enrolled in a prospective, randomized, crossover trial. HD will be compared with online pre-dilution HDF and HDF at increased plasma ionic strength. The ionic strength will be increased using an infusion fluid with hypertonic \\[Na+\\] by isovolumetric adding of a 5000 mmol/L NaCl solution. Blood and dialysate flowrates (250 and 575 mL/min, respectively), treatment time (240 min), and high-flux dialyser (surface area 2.1 sqm, PUREMA H) will be always kept identical. Anticoagulation with standard or fractionated heparin will be unchanged adopted from the patients' routinely used regimen. In both HDF modes, the infusion flow rate will be 125 mL/min. In HDF at increased plasma ionic strength, the infusate \\[Na+\\] will be adjusted to approach 240 mmol/L in plasma entering the dialyser and the dialysate \\[Na+\\] will be set at the technically feasible minimum of 130 mmol/L. Blood samples will be drawn from the arterial and venous blood lines and, if applicable, from the blood tubing connecting the two dialyzers at 0, 15, 30, 60, 120, 180, and 240 min. Samples at 240 min will be drawn after reducing the blood flow rate to 50 mL/min for 30 s and the dialysate flow turned off. A fraction of the spent dialysate will be continuously collected.\n\nRemoval of the free and total fraction of para-cresyl sulfate and indoxyl sulfate will be determined by reduction ratios, dialytic clearances and mass in dialysate\n\nHemocompatibility will be assessed by WBC and platelet counts, free Hb, LDH, C5a and TAT. \\[Na+\\] will be monitored in both arterial (i.e. before NaCl infusion) and venous blood of the extracorporeal system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End-stage renal disease\n* Maintenance hemodialysis or hemodiafiltration for more than 3 months\n* Stable clinical condition\n* \\> 18 years\n\nExclusion Criteria:\n\n* Life expectancy less than 1 year\n* Pregnancy\n* Active infectious disease'}, 'identificationModule': {'nctId': 'NCT01923961', 'briefTitle': 'Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration', 'organization': {'class': 'OTHER', 'fullName': 'EXcorLab GmbH'}, 'officialTitle': 'Impact of an Increased Sodium Chloride Concentration in the Infusion Fluid of Predilution Hemodiafiltration on the Removal of Protein-Bound Uremic Toxins', 'orgStudyIdInfo': {'id': 'KSSA0113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HDF NaCl, Then HD, Then Standard Pre-HDF', 'description': 'Participants first receive hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then receive 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveive 4 hours of standard predilution hemodiafiltration.', 'interventionNames': ['Procedure: HDF NaCl', 'Procedure: Hemodialysis', 'Procedure: Standard Predilution Hemodiafiltration']}, {'type': 'EXPERIMENTAL', 'label': 'HD, Then Standard Pre-HDF, Then HDF NaCl', 'description': 'Participants first receive bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then receive 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveive 4 hours of hemodiafiltration with infusion of 5 M NaCl.', 'interventionNames': ['Procedure: HDF NaCl', 'Procedure: Hemodialysis', 'Procedure: Standard Predilution Hemodiafiltration']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Pre-HDF, Then HDF NaCl, Then HD', 'description': 'Participants first receive standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then receive hemodiafiltration with infusion of 5 M NaCl 4 hours of. After another washout period of 1 week, they reveive 4 hours of bicarbonate hemodialysis.', 'interventionNames': ['Procedure: HDF NaCl', 'Procedure: Hemodialysis', 'Procedure: Standard Predilution Hemodiafiltration']}], 'interventions': [{'name': 'HDF NaCl', 'type': 'PROCEDURE', 'otherNames': ['Hemodialysis', 'Standard Predilution Hemodiafiltration'], 'armGroupLabels': ['HD, Then Standard Pre-HDF, Then HDF NaCl', 'HDF NaCl, Then HD, Then Standard Pre-HDF', 'Standard Pre-HDF, Then HDF NaCl, Then HD']}, {'name': 'Hemodialysis', 'type': 'PROCEDURE', 'otherNames': ['Standard Predilution Hemodiafiltration', 'HDF NaCl'], 'armGroupLabels': ['HD, Then Standard Pre-HDF, Then HDF NaCl', 'HDF NaCl, Then HD, Then Standard Pre-HDF', 'Standard Pre-HDF, Then HDF NaCl, Then HD']}, {'name': 'Standard Predilution Hemodiafiltration', 'type': 'PROCEDURE', 'otherNames': ['HDF NaCl', 'Hemodialysis'], 'armGroupLabels': ['HD, Then Standard Pre-HDF, Then HDF NaCl', 'HDF NaCl, Then HD, Then Standard Pre-HDF', 'Standard Pre-HDF, Then HDF NaCl, Then HD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63820', 'city': 'Elsenfeld', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Dialysis Center Elsenfeld', 'geoPoint': {'lat': 49.84289, 'lon': 9.16355}}], 'overallOfficials': [{'name': 'Detlef H Krieter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuerzburg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EXcorLab GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}