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

Intravenous Access Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299868
• Other study ID #: SEPTIC II
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intravenous Access
• Peripherally Inserted Central Catheter

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View Citation

Cleeland CS. Cancer-related symptoms. Semin Radiat Oncol. 2000 Jul;10(3):175-90. Review. — View Citation

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. — View Citation

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. — View Citation

Ng PK, Ault MJ, Ellrodt AG, Maldonado L. Peripherally inserted central catheters in general medicine. Mayo Clin Proc. 1997 Mar;72(3):225-33. — View Citation

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. Epub 2 — View Citation

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. — View Citation

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. — View Citation

Outcome

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