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

Phase 2

Completed

• Conditions: Peripherally Inserted Central Catheter; Intravenous Access
• Interventions: Device: peripherally inserted central catheter (PICC)

• Registration Number: NCT03299868
• Lead Sponsor: Pusan National University Yangsan Hospital

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).

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-22
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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)

   1. 'current' means bacteremia/fungemia without eradication on follow-up peripheral blood culture
   2. patients with persistent fever (bacteremia or fungemia cannot be ruled out)

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General IV group	peripherally inserted central catheter (PICC)	PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access
Routine PICC group	peripherally inserted central catheter (PICC)	PICC is initially routine insertion at the time of admission of hospice-palliative care unit

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
patient perceived procedure-related distress	5th day after procedure	procedure-related distress during insertion of PICC
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
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
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
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
PICC life span	From date of enrollment until death or discharge/transfer, assess up to 2 years	median survival of PICC

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongsangnam-do, Korea, Republic of