Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT03299868
Status:
COMPLETED
Last Update Posted:
2020-08-25
First Post:
2017-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002406', 'term': 'Catheterization, Peripheral'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Single institution, Open-label, Randomized, Phase 2'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-22', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-09-27', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IV access maintenance success rate', 'timeFrame': 'From date of enrollment until death or discharge/transfer, assess up to 2 years', 'description': 'rate of successful PICC maintenance until death or discharge/transfer'}], 'secondaryOutcomes': [{'measure': 'PICC related complication rate', 'timeFrame': 'From date of enrollment until death or discharge/transfer, assess up to 2 years', 'description': 'rate of any complication which is related with PICC'}, {'measure': 'PICC premature removal rate', 'timeFrame': 'From date of enrollment until date of PICC removal, assess up to 2 years', 'description': 'rate of premature removal such as self-removal or CRBSI before death or discharge'}, {'measure': 'PICC life span', 'timeFrame': 'From date of enrollment until death or discharge/transfer, assess up to 2 years', 'description': 'median survival of PICC'}, {'measure': 'patient perceived procedure-related distress', 'timeFrame': '5th day after procedure', 'description': 'procedure-related distress during insertion of PICC'}, {'measure': 'patient perceived comfort and convenience assessed by a newly developed question in this study', 'timeFrame': '3th to 7th day after enrollment', 'description': 'patient perceived comfort and convenience ("How do participants feel comfort and convenience about the IV access?" at 3th - 7th days after enrollment'}, {'measure': 'colonization of microbiology in PICC', 'timeFrame': 'at the time of PICC removal, assess up to 2 years', 'description': 'Investigator evaluate the colonization of PICC using tip culture at the time of removal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripherally inserted central catheter', 'Terminally ill cancer patients', 'Palliative care'], 'conditions': ['Peripherally Inserted Central Catheter', 'Intravenous Access']}, 'referencesModule': {'references': [{'pmid': '11034629', 'type': 'RESULT', 'citation': 'Cleeland CS. Cancer-related symptoms. Semin Radiat Oncol. 2000 Jul;10(3):175-90. doi: 10.1053/srao.2000.6590.'}, {'pmid': '15800328', 'type': 'RESULT', 'citation': 'Bruera E, Sala R, Rico MA, Moyano J, Centeno C, Willey J, Palmer JL. Effects of parenteral hydration in terminally ill cancer patients: a preliminary study. J Clin Oncol. 2005 Apr 1;23(10):2366-71. doi: 10.1200/JCO.2005.04.069.'}, {'pmid': '16256899', 'type': 'RESULT', 'citation': "Mercadante S, Ferrera P, Girelli D, Casuccio A. Patients' and relatives' perceptions about intravenous and subcutaneous hydration. J Pain Symptom Manage. 2005 Oct;30(4):354-8. doi: 10.1016/j.jpainsymman.2005.04.004."}, {'pmid': '8053751', 'type': 'RESULT', 'citation': 'Lam S, Scannell R, Roessler D, Smith MA. Peripherally inserted central catheters in an acute-care hospital. Arch Intern Med. 1994 Aug 22;154(16):1833-7.'}, {'pmid': '9070197', 'type': 'RESULT', 'citation': 'Ng PK, Ault MJ, Ellrodt AG, Maldonado L. Peripherally inserted central catheters in general medicine. Mayo Clin Proc. 1997 Mar;72(3):225-33. doi: 10.4065/72.3.225.'}, {'pmid': '8392831', 'type': 'RESULT', 'citation': 'Raad I, Davis S, Becker M, Hohn D, Houston D, Umphrey J, Bodey GP. Low infection rate and long durability of nontunneled silastic catheters. A safe and cost-effective alternative for long-term venous access. Arch Intern Med. 1993 Aug 9;153(15):1791-6.'}, {'pmid': '9737634', 'type': 'RESULT', 'citation': 'Smith JR, Friedell ML, Cheatham ML, Martin SP, Cohen MJ, Horowitz JD. Peripherally inserted central catheters revisited. Am J Surg. 1998 Aug;176(2):208-11. doi: 10.1016/s0002-9610(98)00121-4.'}, {'pmid': '27460015', 'type': 'RESULT', 'citation': 'Park K, Jun HJ, Oh SY. Safety, efficacy, and patient-perceived satisfaction of peripherally inserted central catheters in terminally ill cancer patients: a prospective multicenter observational study. Support Care Cancer. 2016 Dec;24(12):4987-4992. doi: 10.1007/s00520-016-3360-6. Epub 2016 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'To establish the IV access strategy for terminally ill cancer patients, using comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (optional PICC group).', 'detailedDescription': 'Reliable intravenous (IV) access is an important issue in terminally ill cancer patients, however, they have limited or no peripheral venous access due to edema or long period of IV therapy. Thus, intravenous access has been provided by Central venous catheter (CVC).\n\nThere are some options for applying CVC in cancer patients; subclavian venous catheter (SVC), chemo-port (CP), and the peripherally inserted central catheter (PICC).\n\nWhen considering the characteristics of terminally ill cancer patients, such as poor general condition and a limited period of survival, PICC could be a safe and effective method for intravenous access.\n\nThere are two previous studies concerned about PICC study in terminally ill cancer patients. They showed that PICC might be overall safe and efficient in terminally ill cancer patients. However, these studies did not evaluate superiority of PICC insertion compared to no insertion and the appropriate time for PICC insertion due to limitation of their design, such as retrospective or single-arm observational study. Thus, strategies of PICC insertion for IV access in terminally ill cancer patients have not been determined until now.\n\nConsidering the favorable results of PICC insertion in previous studies and limited survival time of terminally ill cancer patients, the investigator postulated that routine PICC insertion at the time of admission for terminal care would be effective for IV access.\n\nThus, the investigator assumed that initially routine PICC insertion would be non-inferior in maintenance success rate / and complication rate compared to general IV access. In addition, it would be superior in patient-perceived satisfaction. The inveistigator will undertake a randomized phase II study to confirm the hypothesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Cancer patients with histologically or cytologically confirmed malignancy and fulfilled all of the following conditions\n2. Patients with expected survival time of 3 months or less due to a progressive disease without additional anticancer treatment. (However, palliative radiation treatment for symptom control is allowed.)\n3. Patients who need the IV access route continuously for hydration or medication.\n4. Age18 or older\n5. Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed about all pertinent aspects of the trial prior to enrollment\n\nExclusion Criteria:\n\n1. Patients who showed severe coagulopathy such as thrombocytopenia (Platelet count ≤ 20,000/mm2) or international normalized ratio (INR) prolongation (≥2.0 ) in spite of treatment\n2. Patients who have an evidence of current sepsis (bacteremia or fungemia)\n\n 1. 'current' means bacteremia/fungemia without eradication on follow-up peripheral blood culture\n 2. patients with persistent fever (bacteremia or fungemia cannot be ruled out)\n3. Patients who is impracticable to PICC insertion due to uncontrolled behavioral disorders"}, 'identificationModule': {'nctId': 'NCT03299868', 'briefTitle': 'Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'Comparison of Safety, Efficacy, and Patient-perceived Satisfaction Between Initial Routine Peripherally Inserted Central Catheters Insertion and General Intravenous Access in Terminally Ill Cancer Patients: A Randomized Phase II Study', 'orgStudyIdInfo': {'id': 'SEPTIC II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Routine PICC group', 'description': 'PICC is initially routine insertion at the time of admission of hospice-palliative care unit', 'interventionNames': ['Device: peripherally inserted central catheter (PICC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General IV group', 'description': 'PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access', 'interventionNames': ['Device: peripherally inserted central catheter (PICC)']}], 'interventions': [{'name': 'peripherally inserted central catheter (PICC)', 'type': 'DEVICE', 'description': 'comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (general IV group)', 'armGroupLabels': ['General IV group', 'Routine PICC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Kwonoh Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, clinical research', 'investigatorFullName': 'Kwonoh Park, MD phD', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}