Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:37 AM
Study NCT ID:
NCT07412834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safely Disconnect From the Dialysis Machine in an Emergency Situation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 620}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequate information about withdrawal from the machine', 'timeFrame': 'At the begining of the study', 'description': 'Data were collected using a checklist that assessed whether patients knew how to disconnect themselves from the dialysis machine in emergency situations.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dialysis; Complications']}, 'referencesModule': {'references': [{'pmid': '30776874', 'type': 'RESULT', 'citation': 'Yoo KD, Kim HJ, Kim Y, Park JY, Shin SJ, Han SH, Kim DK, Lim CS, Kim YS. Disaster preparedness for earthquakes in hemodialysis units in Gyeongju and Pohang, South Korea. Kidney Res Clin Pract. 2019 Mar 31;38(1):15-24. doi: 10.23876/j.krcp.18.0058.'}, {'pmid': '39046087', 'type': 'RESULT', 'citation': 'Sever MS, Vanholder R, Lameire N. Disaster preparedness for people with kidney disease and kidney healthcare providers. Curr Opin Nephrol Hypertens. 2024 Nov 1;33(6):613-620. doi: 10.1097/MNH.0000000000001014. Epub 2024 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'In a dialysis unit, it is not possible for healthcare personnel to disconnect all patients from the machines simultaneously in the event of an emergency. Therefore, allowing patients who are able to safely disconnect themselves from the machine to do so, while healthcare staff assist those who are unable, will help minimize harm during such situations. For this reason, "clamp and cut/cap" training should be provided to all patients, and a note indicating whether the patient is able to disconnect themselves from the machine in an emergency should be included in their medical records. Importantly, this training should not be limited to theoretical instruction but should also include hands-on practice and simulation-based training to reinforce learning and transform knowledge into practical skills.', 'detailedDescription': "In the literature, only one known study was identified that investigated the level of knowledge of dialysis patients regarding how to disconnect themselves from the machine during a natural disaster. That study reported that only a small proportion of patients knew how to terminate dialysis treatment in an emergency situation. However, the assessment in that study was limited to patients' knowledge level, and the procedural steps of the disconnection process were not evaluated.\n\nMoreover, studies conducted in different countries indicate that dialysis patients have deficiencies in disaster preparedness and emergency procedures, highlighting the need for structured educational programs in this area. To the best of our knowledge, this study will be the first to evaluate both the knowledge level and the procedural steps related to self-disconnection in dialysis patients.\n\nThe aim of this study is to assess hemodialysis patients' knowledge regarding how to disconnect themselves from the machine in an emergency situation, as well as the accuracy of the procedural steps involved."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study was conducted in a total of eight dialysis centers: three in Türkiye, two in Portugal, and one each in the Poland, and Greece', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and older who had been receiving hemodialysis treatment for at least three months\n* Had no conditions that would impair communication\n* Voluntarily agreed to participate were included in the study\n\nExclusion Criteria:\n\n* Patients who declined to provide voluntary consent were excluded from the study'}, 'identificationModule': {'nctId': 'NCT07412834', 'briefTitle': 'Safely Disconnect From the Dialysis Machine in an Emergency Situation', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Do Hemodialysis Patients Know How to Safely Disconnect Themselves From the Dialysis Machine in an Emergency Situation?: An International, Multicenter Study', 'orgStudyIdInfo': {'id': '2025-16'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Emergency withdraw', 'type': 'OTHER', 'description': "A questionnaire was administered to assess patients' level of knowledge regarding self-disconnection from the hemodialysis machine."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nurten Ozen, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nurten Ozen', 'investigatorAffiliation': 'Istanbul University'}}}}