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

NCT03299868 | Completed Phase 2

• 1 other identifier: SEPTIC II
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripherally Inserted Central Catheter; Intravenous Access

Keywords

Peripherally inserted central catheter; Terminally ill cancer patients; Palliative care

Outcome Measures

Primary Outcomes (1)

• IV access maintenance success rate

  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 Outcomes (6)

• PICC related complication rate

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

• PICC premature removal rate

  From date of enrollment until date of PICC removal, assess up to 2 years

• PICC life span

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

• patient perceived procedure-related distress

  5th day after procedure

• patient perceived comfort and convenience assessed by a newly developed question in this study

  3th to 7th day after enrollment

Study Arms (2)

Routine PICC group

EXPERIMENTAL

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

Device: peripherally inserted central catheter (PICC)

General IV group

ACTIVE COMPARATOR

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)

Interventions

peripherally inserted central catheter (PICC) 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; Routine PICC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Related Publications (8)

• Cleeland CS. Cancer-related symptoms. Semin Radiat Oncol. 2000 Jul;10(3):175-90. doi: 10.1053/srao.2000.6590.

  PMID: 11034629 RESULT

• Bruera E, Sala R, Rico MA, Moyano J, Centeno C, Willey J, Palmer JL. Effects of parenteral hydration in terminally ill cancer patients: a preliminary study. J Clin Oncol. 2005 Apr 1;23(10):2366-71. doi: 10.1200/JCO.2005.04.069.

  PMID: 15800328 RESULT

• Mercadante S, Ferrera P, Girelli D, Casuccio A. Patients' and relatives' perceptions about intravenous and subcutaneous hydration. J Pain Symptom Manage. 2005 Oct;30(4):354-8. doi: 10.1016/j.jpainsymman.2005.04.004.

  PMID: 16256899 RESULT

• Lam S, Scannell R, Roessler D, Smith MA. Peripherally inserted central catheters in an acute-care hospital. Arch Intern Med. 1994 Aug 22;154(16):1833-7.

  PMID: 8053751 RESULT

• Ng PK, Ault MJ, Ellrodt AG, Maldonado L. Peripherally inserted central catheters in general medicine. Mayo Clin Proc. 1997 Mar;72(3):225-33. doi: 10.4065/72.3.225.

  PMID: 9070197 RESULT

• Raad I, Davis S, Becker M, Hohn D, Houston D, Umphrey J, Bodey GP. Low infection rate and long durability of nontunneled silastic catheters. A safe and cost-effective alternative for long-term venous access. Arch Intern Med. 1993 Aug 9;153(15):1791-6.

  PMID: 8392831 RESULT

• 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.

  PMID: 9737634 RESULT

• 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.

  PMID: 27460015 RESULT

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Kwonoh Park, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, clinical research

Model Details: Prospective, Single institution, Open-label, Randomized, Phase 2

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: October 3, 2017
• Study Start: May 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)