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

NCT ID: NCT03299868

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2020-06-30

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.

Conditions

Peripherally Inserted Central Catheter; Intravenous Access

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Routine PICC group

PICC is initially routine insertion at the time of admission of hospice-palliative care unit

Group Type: EXPERIMENTAL

peripherally inserted central catheter (PICC)

Intervention Type: DEVICE

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)

General IV group

PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access

Group Type: ACTIVE_COMPARATOR

peripherally inserted central catheter (PICC)

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kwonoh Park, MD phD

Professor, clinical research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwonoh Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Countries

South Korea

References

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Reference Type: RESULT

PMID: 9070197 (View on PubMed)

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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.

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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.

Reference Type: RESULT

PMID: 27460015 (View on PubMed)

Other Identifiers

SEPTIC II

Identifier Type: -

Identifier Source: org_study_id