CompletedPhase 2

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

South Korea66 participantsStarted 2017-05-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Cancer patients with histologically or cytologically confirmed malignancy and fulfilled all of the following conditions
✓. 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.)
✓. Patients who need the IV access route continuously for hydration or medication.
✓. Age18 or older
✓. 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

✕. 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
✕. Patients who have an evidence of current sepsis (bacteremia or fungemia)
✕. 'current' means bacteremia/fungemia without eradication on follow-up peripheral blood culture
✕. patients with persistent fever (bacteremia or fungemia cannot be ruled out)
✕. Patients who is impracticable to PICC insertion due to uncontrolled behavioral disorders

What they're measuring

IV access maintenance success rate

Timeframe: From date of enrollment until death or discharge/transfer, assess up to 2 years

Trial details

NCT IDNCT03299868

SponsorPusan National University Yangsan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-30

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