Patients Cannulated With Both PICC and CICC.PICCNCT00988871
Comparison of Central Venous Pressures (CVPs) Measured From Peripherally Inserted Central Catheters (PICC) and CICC in Liver Transplantation Recipients
An observational study of Patients Cannulated With Both PICC and CICC. and The Rapidly Fluctuating Hemodynamics During LT., run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Background: Central venous pressure (CVP) monitoring from the peripherally inserted central venous catheter (PICC) has not often been used because of the higher inherent resistance of the PICC due to its longer length and narrower lumen. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Cannulated With Both PICC and CICC., The Rapidly Fluctuating Hemodynamics During LT.
- What is being tested?
- PICC, CICC
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Jun 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients who had been scheduled for elective liver transplant surgery, and placed with both PICC and CICC.
Who may be able to join
- Adult patients who had been scheduled for elective liver transplant surgery
- Patients who had been placed with both PICC and CICC at anesthetic induction
Who cannot join
- Failure to insert PICC
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center
323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Comparison of the Central Venous Pressures Measured From the Peripherally Inserted Antecubital Central Catheters and the Internal Jugular Vein Central Catheters in Liver Transplantation Recipients
Background: Central venous pressure (CVP) monitoring from the peripherally inserted central venous catheter (PICC) has not often been used because of the higher inherent resistance of the PICC due to its longer length and narrower lumen. The objective of this study was to assess the reliability of the CVP measured from PICCs as a predictor of the CVP measured from CICCs in the setting of rapidly fluctuating hemodynamic conditions during liver transplantation.
Read the detailed description
According to the protocol of LT in our hospital, a PICC is concomitantly inserted with the pulmonary artery catheter (PAC) and 9-Fr advanced venous access (AVA) catheter for the LT recipient at anesthetic induction. PAC and AVA catheter are usually removed on the second postoperative day, and instead the PICC is used for the postoperative infusion of prostaglandin E1 which is very irritable to small peripheral vein. So we fortunately had chance to measure the CVPs from both CICC and PICC simultaneously in the same patients.
Methods: We measured the CVPs from the CICC and the PICC simultaneously during each main surgical period of adult liver transplantation (preanhepatic, anhepatic, reperfusion, and neo-hepatic period). Data are presented as means ± standard deviation. Statistical analysis was performed using simple linear regression analysis to observe whether changes in the PICCP were paralleled by simultaneous changes in the CICCP. Bland-Altman analysis was used to determine the degree of agreement between the two devices. Analysis of variance was performed to study whether there were changes in the CVP agreement profiles in regard to the different time periods of LT. Differences were regarded as being statistically significant when p values were less than 0.05.
(This observational study has been completed already.)
- Conditions
- Patients Cannulated With Both PICC and CICC., The Rapidly Fluctuating Hemodynamics During LT.
- Being tested
- PICC, CICC
- Keywords
- PICC (peripherally inserted central venous catheter), CICC (centrally inserted central venous catheter, CVP (central venous pressure), LT (liver transplantation), agreement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC, CICCDevice
PICC insertion, CICC (advanced venous access with pulmonary artery catheter) insertion
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation (LT) recipients | LT recipients who had both PICC and CICC at the same time according to the LT protocol of our hospital Receives: Device: PICC, CICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
PICCP: CVP measured from peripherally inserted antecubital central catheters in liver transplantation recipients
Measured: every 10 minutes during the liver transplantation
CICCP: CVP from IJV central catheters in liver transplantation recipients
Measured: every 10 minutes during the liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Cannulated With Both PICC and CICC.Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- So-Hee Park, PhD, Study director, Department of cancer registration and biostatistics branch, Research institute and hospital, National cancer center, Republic of KoreaSoon-Ae Lee, MD.PhD., Study director, Department of Anesthesiology and pain medicine, Research institute and hospital, National cancer center, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988871
- Sponsor's protocol ID
- PICC1342
- Acronym
- PICC
- Status last verified
- Oct 2009
- First submitted
- 1 Oct 2009
- Last updated
- 2 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Black IH, Blosser SA, Murray WB. Central venous pressure measurements: peripherally inserted catheters versus centrally inserted catheters. Crit Care Med. 2000 Dec;28(12):3833-6. doi: 10.1097/00003246-200012000-00014.
PubMed 11153622McLemore EC, Tessier DJ, Rady MY, Larson JS, Mueller JT, Stone WM, Fowl RJ, Patel BM. Intraoperative peripherally inserted central venous catheter central venous pressure monitoring in abdominal aortic aneurysm reconstruction. Ann Vasc Surg. 2006 Sep;20(5):577-81. doi: 10.1007/s10016-006-9108-x. Epub 2006 Jul 27.
PubMed 16871437
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Central Venous Pressures Measured From the Peripherally Inserted Antecubital Central Catheters and the Internal Jugular Vein Central Catheters in Liver Transplantation Recipients
- ClinicalTrials.gov ID
- NCT00988871
- Acronym / sponsor ID
- PICC / PICC1342
- Conditions
- Patients Cannulated With Both PICC and CICC., The Rapidly Fluctuating Hemodynamics During LT.
- Keywords
- PICC (peripherally inserted central venous catheter), CICC (centrally inserted central venous catheter, CVP (central venous pressure), LT (liver transplantation), agreement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Oct 2009 (estimated)
- 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.
Background: Central venous pressure (CVP) monitoring from the peripherally inserted central venous catheter (PICC) has not often been used because of the higher inherent resistance of the PICC due to its longer length and narrower lumen. The objective of this study was to assess the reliability of the CVP measured from PICCs as a predictor of the CVP measured from CICCs in the setting of rapidly fluctuating hemodynamic conditions during liver transplantation.
Detailed description
According to the protocol of LT in our hospital, a PICC is concomitantly inserted with the pulmonary artery catheter (PAC) and 9-Fr advanced venous access (AVA) catheter for the LT recipient at anesthetic induction. PAC and AVA catheter are usually removed on the second postoperative day, and instead the PICC is used for the postoperative infusion of prostaglandin E1 which is very irritable to small peripheral vein. So we fortunately had chance to measure the CVPs from both CICC and PICC simultaneously in the same patients.
Methods: We measured the CVPs from the CICC and the PICC simultaneously during each main surgical period of adult liver transplantation (preanhepatic, anhepatic, reperfusion, and neo-hepatic period). Data are presented as means ± standard deviation. Statistical analysis was performed using simple linear regression analysis to observe whether changes in the PICCP were paralleled by simultaneous changes in the CICCP. Bland-Altman analysis was used to determine the degree of agreement between the two devices. Analysis of variance was performed to study whether there were changes in the CVP agreement profiles in regard to the different time periods of LT. Differences were regarded as being statistically significant when p values were less than 0.05.
(This observational study has been completed already.)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation (LT) recipients | – | Device: PICC, CICCLT recipients who had both PICC and CICC at the same time according to the LT protocol of our hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients who had been scheduled for elective liver transplant surgery, and placed with both PICC and CICC.
Key inclusion criteria (2 listed)
- Adult patients who had been scheduled for elective liver transplant surgery
- Patients who had been placed with both PICC and CICC at anesthetic induction
Key exclusion criteria (1 listed)
- Failure to insert PICC
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 |
|---|---|---|
| PICC, CICCPICC insertion, CICC (advanced venous access with pulmonary artery catheter) insertion | Device | Liver transplantation (LT) recipients |
Primary outcome
PICCP: CVP measured from peripherally inserted antecubital central catheters in liver transplantation recipients
Time frame: every 10 minutes during the liver transplantation
CICCP: CVP from IJV central catheters in liver transplantation recipients
Time frame: every 10 minutes during the liver transplantation
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 2 Oct 2009.
- Results publication: PubMed 11153622Black IH, Blosser SA, Murray WB. Central venous pressure measurements: peripherally inserted catheters versus centrally inserted catheters. Crit Care Med. 2000 Dec;28(12):3833-6. doi: 10.1097/00003246-200012000-00014.
- Results publication: PubMed 16871437McLemore EC, Tessier DJ, Rady MY, Larson JS, Mueller JT, Stone WM, Fowl RJ, Patel BM. Intraoperative peripherally inserted central venous catheter central venous pressure monitoring in abdominal aortic aneurysm reconstruction. Ann Vasc Surg. 2006 Sep;20(5):577-81. doi: 10.1007/s10016-006-9108-x. Epub 2006 Jul 27.
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.
So-Hee Park, PhD study director
Department of cancer registration and biostatistics branch, Research institute and hospital, National cancer center, Republic of Korea
Soon-Ae Lee, MD.PhD. study director
Department of Anesthesiology and pain medicine, Research institute and hospital, National cancer center, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Cannulated With Both PICC and CICC. and The Rapidly Fluctuating Hemodynamics During LT., run by National Cancer Center, Korea 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 2 inclusion and 1 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 2 Oct 2009. 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.
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?
PICCP: CVP measured from peripherally inserted antecubital central catheters in liver transplantation recipients (time frame: every 10 minutes during the liver transplantation). The study lists 2 primary outcomes in all. 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 NCT00988871, which also lists 2 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 2 Oct 2009.