Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients

• Sponsor: Pusan National University Yangsan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03299868
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Actual Duration (Months): 38
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Peripherally Inserted Central Catheter; Intravenous Access	Device: peripherally inserted central catheter (PICC)	Phase 2

Detailed Description

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).

There are some options for applying CVC in cancer patients; subclavian venous catheter (SVC), chemo-port (CP), and the peripherally inserted central catheter (PICC).

When 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.

There 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.

Considering 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.

Thus, 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, Single institution, Open-label, Randomized, Phase 2Prospective, Single institution, Open-label, Randomized, Phase 2
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Routine PICC group PICC is initially routine insertion at the time of admission of hospice-palliative care unit	Device: peripherally inserted central catheter (PICC); 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)
Active Comparator: General IV group PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access	Device: peripherally inserted central catheter (PICC); 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)

Outcome Measures

Primary Outcome Measures

1. IV access maintenance success rate [From date of enrollment until death or discharge/transfer, assess up to 2 years]

   rate of successful PICC maintenance until death or discharge/transfer

Secondary Outcome Measures

1. PICC related complication rate [From date of enrollment until death or discharge/transfer, assess up to 2 years]

   rate of any complication which is related with PICC

2. PICC premature removal rate [From date of enrollment until date of PICC removal, assess up to 2 years]

   rate of premature removal such as self-removal or CRBSI before death or discharge

3. PICC life span [From date of enrollment until death or discharge/transfer, assess up to 2 years]

   median survival of PICC

4. patient perceived procedure-related distress [5th day after procedure]

   procedure-related distress during insertion of PICC

5. patient perceived comfort and convenience assessed by a newly developed question in this study [3th to 7th day after enrollment]

   patient perceived comfort and convenience ("How do participants feel comfort and convenience about the IV access?" at 3th - 7th days after enrollment

6. colonization of microbiology in PICC [at the time of PICC removal, assess up to 2 years]

   Investigator evaluate the colonization of PICC using tip culture at the time of removal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Cancer patients with histologically or cytologically confirmed malignancy and fulfilled all of the following conditions

2. 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.)

3. Patients who need the IV access route continuously for hydration or medication.

4. Age18 or older

5. 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

Exclusion Criteria:

1. 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

2. Patients who have an evidence of current sepsis (bacteremia or fungemia)

3. 'current' means bacteremia/fungemia without eradication on follow-up peripheral blood culture

4. patients with persistent fever (bacteremia or fungemia cannot be ruled out)

5. Patients who is impracticable to PICC insertion due to uncontrolled behavioral disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do	Korea, Republic of	50612

Sponsors and Collaborators

• Pusan National University Yangsan Hospital

Investigators

• Principal Investigator: Kwonoh Park, MD, PhD, Pusan National University Yangsan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kwonoh Park, MD phD, Professor, clinical research, Pusan National University Yangsan Hospital
• ClinicalTrials.gov Identifier: NCT03299868
• Other Study ID Numbers: SEPTIC II
• First Posted: Oct 3, 2017
• Last Update Posted: Aug 25, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kwonoh Park, MD phD, Professor, clinical research, Pusan National University Yangsan Hospital: Peripherally inserted central catheter; Terminally ill cancer patients; Palliative care

Study Results

No Results Posted as of Aug 25, 2020