Peripherally Inserted Central CatheterPhase 2NCT03299868
Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients
A Phase 2 study testing peripherally inserted central catheter (PICC) in people with Peripherally Inserted Central Catheter and Intravenous Access, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripherally Inserted Central Catheter, Intravenous Access
- What is being tested?
- peripherally inserted central catheter (PICC)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2017to 30 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
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
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).
Read the 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.
- Being tested
- peripherally inserted central catheter (PICC)
- Keywords
- Peripherally inserted central catheter, Terminally ill cancer patients, Palliative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Routine PICC group | Experimental | PICC is initially routine insertion at the time of admission of hospice-palliative care unit Receives: 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 Receives: Device: peripherally inserted central catheter (PICC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IV access maintenance success rate
rate of successful PICC maintenance until death or discharge/transfer
Measured: From date of enrollment until death or discharge/transfer, assess up to 2 years
Secondary outcomes (6)
PICC related complication rate
rate of any complication which is related with PICC
Measured: From date of enrollment until death or discharge/transfer, assess up to 2 years
PICC premature removal rate
rate of premature removal such as self-removal or CRBSI before death or discharge
Measured: From date of enrollment until date of PICC removal, assess up to 2 years
PICC life span
median survival of PICC
Measured: From date of enrollment until death or discharge/transfer, assess up to 2 years
patient perceived procedure-related distress
procedure-related distress during insertion of PICC
Measured: 5th day after procedure
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
Measured: 3th to 7th day after enrollment
colonization of microbiology in PICC
Investigator evaluate the colonization of PICC using tip culture at the time of removal
Measured: at the time of PICC removal, assess up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 May 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Peripherally Inserted Central CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Single institution, Open-label, Randomized, Phase 2
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwonoh Park, MD phD, Pusan National University Yangsan Hospital
- Investigators
- Kwonoh Park, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299868
- Sponsor's protocol ID
- SEPTIC II
- Status last verified
- Aug 2020
- First submitted
- 19 Sep 2017
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cleeland CS. Cancer-related symptoms. Semin Radiat Oncol. 2000 Jul;10(3):175-90. doi: 10.1053/srao.2000.6590.
PubMed 11034629Bruera 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.
PubMed 15800328Mercadante 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.
PubMed 16256899Lam 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.
PubMed 8053751Ng 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.
PubMed 9070197Raad 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.
PubMed 8392831Smith 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.
PubMed 9737634Park 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.
PubMed 27460015
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03299868
- Acronym / sponsor ID
- SEPTIC II
- Keywords
- Peripherally inserted central catheter, Terminally ill cancer patients, Palliative care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Single institution, Open-label, Randomized, Phase 2
| Arm | Type | Receives |
|---|---|---|
| Routine PICC group | Experimental | Device: peripherally inserted central catheter (PICC)PICC is initially routine insertion at the time of admission of hospice-palliative care unit |
| General IV group | Active comparator | Device: peripherally inserted central catheter (PICC)PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
- Patients who is impracticable to PICC insertion due to uncontrolled behavioral disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | General IV group, Routine PICC group |
Primary outcome
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
6 secondary outcomes
PICC related complication rate
Time frame: 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
PICC life span
Time frame: 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
patient perceived comfort and convenience assessed by a newly developed question in this study
Time frame: 3th to 7th day after enrollment
colonization of microbiology in PICC
Time frame: at the time of PICC removal, assess up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Results publication: PubMed 11034629Cleeland CS. Cancer-related symptoms. Semin Radiat Oncol. 2000 Jul;10(3):175-90. doi: 10.1053/srao.2000.6590.
- Results publication: PubMed 15800328Bruera 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.
- Results publication: PubMed 16256899Mercadante 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.
- Results publication: PubMed 8053751Lam 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.
- Results publication: PubMed 9070197Ng 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.
- Results publication: PubMed 8392831Raad 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.
- Results publication: PubMed 9737634Smith 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.
- Results publication: PubMed 27460015Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwonoh Park, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peripherally inserted central catheter (PICC) in people with Peripherally Inserted Central Catheter and Intravenous Access, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IV access maintenance success rate (time frame: From date of enrollment until death or discharge/transfer, assess up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299868, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020; AzTrials last refreshed its copy on 27 Oct 2026.