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

August 22, 2020 updated by: Kwonoh Park, MD phD, Pusan National University Yangsan Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IV access maintenance success rate
Time Frame: From date of enrollment until death or discharge/transfer, assess up to 2 years
rate of successful PICC maintenance until death or discharge/transfer
From date of enrollment until death or discharge/transfer, assess up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PICC related complication rate
Time Frame: From date of enrollment until death or discharge/transfer, assess up to 2 years
rate of any complication which is related with PICC
From date of enrollment until death or discharge/transfer, assess up to 2 years
PICC premature removal rate
Time Frame: 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
From date of enrollment until date of PICC removal, assess up to 2 years
PICC life span
Time Frame: From date of enrollment until death or discharge/transfer, assess up to 2 years
median survival of PICC
From date of enrollment until death or discharge/transfer, assess up to 2 years
patient perceived procedure-related distress
Time Frame: 5th day after procedure
procedure-related distress during insertion of PICC
5th day after procedure
patient perceived comfort and convenience assessed by a newly developed question in this study
Time Frame: 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
3th to 7th day after enrollment
colonization of microbiology in PICC
Time Frame: 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
at the time of PICC removal, assess up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (ACTUAL)

October 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 22, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SEPTIC II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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