Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT04274556
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2020-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Recovery Time and Affecting Factors in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ozenurten@yahoo.com.tr', 'phone': '+90 212 213 64 86', 'title': 'Nurten OZEN', 'organization': 'Demiroglu Bilim University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 4 weeks', 'description': 'Side effects/other adverse events were not monitored', 'eventGroups': [{'id': 'EG000', 'title': 'Post-dialysis Recovery Group', 'description': 'Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-dialysis Recovery Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-dialysis Recovery Group', 'description': 'Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account'}], 'classes': [{'categories': [{'measurements': [{'value': '278.02', 'spread': '209.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 days', 'description': 'Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Intradialytic Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-dialysis Recovery Group', 'description': 'Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account'}], 'classes': [{'title': 'Existing of intradialytic symptoms', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Absent of intradialytic symptoms', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days', 'description': 'It is defined in the European Best Practice Guideline (EBPG) as a decrease of 20 mmHg or more in the systolic blood pressure or 10 mmHg or more in the mean arterial blood pressure together with symptoms requiring nursing intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rate of Dialysis Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-dialysis Recovery Group', 'description': 'Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account'}], 'classes': [{'categories': [{'measurements': [{'value': '19.10', 'spread': '14.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 days', 'description': 'It was identified with Dialysis Symptom Index (DSI). DSI consists of 30 items. We queried the subjects regarding symptoms in the last 7 days. The effect was evaluated with a Likert type scale from 0 to 4, representing "not at all" to "significantly". The total score of the DSI ranges from 0 to 150. A score of zero reflects no symptoms while increasing total scores reflect increasing effects of the symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Post-dialysis Recovery Group', 'description': 'Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Post-dialysis Recovery Group', 'description': 'Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '86', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-11', 'size': 423418, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-12T17:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2020-02-15', 'resultsFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-12', 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-dialysis Recovery Time', 'timeFrame': 'Up to 7 days', 'description': 'Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.'}, {'measure': 'Number of Participants With Intradialytic Hypotension', 'timeFrame': 'Up to 7 days', 'description': 'It is defined in the European Best Practice Guideline (EBPG) as a decrease of 20 mmHg or more in the systolic blood pressure or 10 mmHg or more in the mean arterial blood pressure together with symptoms requiring nursing intervention.'}, {'measure': 'Rate of Dialysis Symptoms', 'timeFrame': 'Up to 7 days', 'description': 'It was identified with Dialysis Symptom Index (DSI). DSI consists of 30 items. We queried the subjects regarding symptoms in the last 7 days. The effect was evaluated with a Likert type scale from 0 to 4, representing "not at all" to "significantly". The total score of the DSI ranges from 0 to 150. A score of zero reflects no symptoms while increasing total scores reflect increasing effects of the symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dialysis; Complications', 'Life Quality']}, 'referencesModule': {'references': [{'pmid': '22941875', 'type': 'BACKGROUND', 'citation': 'Bossola M, Di Stasio E, Antocicco M, Silvestri P, Tazza L. Variables associated with time of recovery after hemodialysis. J Nephrol. 2013 Jul-Aug;26(4):787-92. doi: 10.5301/jn.5000198. Epub 2012 Aug 31.'}, {'pmid': '28419668', 'type': 'BACKGROUND', 'citation': 'Bossola M, Marzetti E, Di Stasio E, Monteburini T, Cenerelli S, Mazzoli K, Parodi E, Sirolli V, Santarelli S, Ippoliti F, Nebiolo PE, Bonomini M, Melatti R, Vulpio C. Prevalence and associated variables of post-dialysis fatigue: Results of a prospective multicentre study. Nephrology (Carlton). 2018 Jun;23(6):552-558. doi: 10.1111/nep.13059.'}, {'pmid': '30860667', 'type': 'BACKGROUND', 'citation': 'Davenport A, Guirguis A, Almond M, Day C, Chilcot J, Wellsted D, Farrington K. Comparison of characteristics of centers practicing incremental vs. conventional approaches to hemodialysis delivery - postdialysis recovery time and patient survival. Hemodial Int. 2019 Jul;23(3):288-296. doi: 10.1111/hdi.12743. Epub 2019 Mar 12.'}, {'pmid': '33497021', 'type': 'DERIVED', 'citation': 'Ozen N, Cepken T, Tosun B. Do biochemical parameters and intradialytic symptoms affect post-dialysis recovery time? A prospective, descriptive study. Ther Apher Dial. 2021 Dec;25(6):899-907. doi: 10.1111/1744-9987.13624. Epub 2021 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'Patients undergoing hemodialysis (HD) can experience symptoms such as lassitude, pain, muscle cramps, nausea, vomiting, constipation, diarrhea, rash, skin dryness, sleep disorders, and emotional and sexual problems after the treatment. Many chronic HD patients do not feel well after the treatment sessions and need some time to recover. This recovery time is defined as the time required to recover from the feelings of lassitude and fatigue.', 'detailedDescription': 'The recovery time not only decreases the quality of life but also increases the risk of mortality and morbidity. As a prolonged recovery time affects both the patients and the healthcare professionals and caregivers, there has been increased interest on determining the modifiable treatment-related factors in the international literature. The patients are limited in their daily living activities at home and at work during this period and a significant amount of time is therefore required to go back to normal life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Being on HD for 4 hours a day on 3 days per week for at least 6 months and 18 years or older', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Being on HD for 4 hours a day on 3 days per week for at least 6 months\n* No communication problem\n* Volunteering to participate to the study\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Shorter being on HD for 4 hours a day on 3 days per week for at least 6 months\n* Have communication problem\n* Not volunteering to participate to the study'}, 'identificationModule': {'nctId': 'NCT04274556', 'briefTitle': 'Recovery Time and Affecting Factors in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Demiroglu Bilim University'}, 'officialTitle': 'Do Biochemical Parameters and Intradialytic Symptoms Affect Post-dialysis Recovery Time?: A Cross-sectional Study', 'orgStudyIdInfo': {'id': '03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Post-dialysis recovery group', 'type': 'OTHER', 'description': 'Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34360', 'city': 'Istanbul', 'state': 'Sisli', 'country': 'Turkey (Türkiye)', 'facility': 'Demiroglu Bİlim University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34384', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Demiroglu Bilim University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Demiroglu Bilim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nurten Ozen', 'investigatorAffiliation': 'Istanbul Demiroglu Bilim University'}}}}