Peripherally Inserted Central CathetersNCT03834675
Suitability of PICC for Transpulmonary Thermodilution Compared to CICC
A study testing transpulmonary thermodilution in people with Peripherally Inserted Central Catheters and CVC, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripherally Inserted Central Catheters, CVC, Transpulmonary Thermodilution
- What is being tested?
- transpulmonary thermodilution
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 31 Jan 2019
- Phase
- Interventional
- 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
- adult patients (≥18 years) admitted to the ICU
- Patients requiring hemodynamic monitoring using EV1000TM
- Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed)
Who cannot join
- body weight <40 kg
- severe aortic regurgitation or intra-cardiac shunt
- treatment with an intra-aortic balloon pump
- contraindication for placement of PICC, CICC or a femoral arterial catheter
- abdominal aneurism
- extracorporeal circulation
- pregnancy
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Peripherally Inserted Central Catheters (PICC) Suitable for Cardiac Output Assessment With Trans-pulmonary Thermodilution
Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study we try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.
- Conditions
- Peripherally Inserted Central Catheters, CVC, Transpulmonary Thermodilution, Hemodynamic Monitoring
- Being tested
- transpulmonary thermodilution
- Keywords
- PICC, shock, cardiac output
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transpulmonary thermodilutionDiagnostic test
Thermodilution was attempted via PICC and via CICC
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Index comparison via PICC
comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC.
Measured: One hour
Secondary outcomes (2)
Comparison 4Fr PICCs to CICC
Comparison of single-lumen 4 Fr PICCs to CICC in their reliability of assessing cardiac output
Measured: one hour
Comparison 5Fr PICCs to CICC
Comparison of dual-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Jun 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripherally Inserted Central CathetersStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Claudio Sandroni, Sofia Cacciola, Antonio Maria Dell Anna, Mauro Pittiruti, Maria Giuseppina Annetta, Cesare Colosimo, Antonelli, Massimo, M.D.
- Responsible party
- Principal investigator, Dr.ssa Sonia D'Arrigo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Massimo Antonelli, MD, Study chair, Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834675
- Sponsor's protocol ID
- PICC -CICC for TPTD
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
D'Arrigo S, Sandroni C, Cacciola S, Dell'Anna AM, Pittiruti M, Annetta MG, Colosimo C, Antonelli M. Are Peripherally Inserted Central Catheters Suitable for Cardiac Output Assessment With Transpulmonary Thermodilution? Crit Care Med. 2019 Oct;47(10):1356-1361. doi: 10.1097/CCM.0000000000003917.
PubMed 31356470
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Peripherally Inserted Central Catheters (PICC) Suitable for Cardiac Output Assessment With Trans-pulmonary Thermodilution
- ClinicalTrials.gov ID
- NCT03834675
- Acronym / sponsor ID
- PICC -CICC for TPTD
- Conditions
- Peripherally Inserted Central Catheters, CVC, Transpulmonary Thermodilution, Hemodynamic Monitoring
- Keywords
- PICC, shock, cardiac output
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Claudio Sandroni, Sofia Cacciola, Antonio Maria Dell Anna, Mauro Pittiruti, Maria Giuseppina Annetta, Cesare Colosimo, Antonelli, Massimo, M.D.
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 8 Feb 2019 (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.
Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study we try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.
Study design
- Primary purpose
- Other
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients (≥18 years) admitted to the ICU
- Patients requiring hemodynamic monitoring using EV1000TM
- Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed)
Key exclusion criteria (8 listed)
- body weight <40 kg
- severe aortic regurgitation or intra-cardiac shunt
- treatment with an intra-aortic balloon pump
- contraindication for placement of PICC, CICC or a femoral arterial catheter
- abdominal aneurism
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 |
|---|---|---|
| transpulmonary thermodilutionThermodilution was attempted via PICC and via CICC | Diagnostic test | – |
Primary outcome
Cardiac Index comparison via PICC
Time frame: One hour
comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC.
2 secondary outcomes
Comparison 4Fr PICCs to CICC
Time frame: one hour
Comparison 5Fr PICCs to CICC
Time frame: one hour
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 27 Jan 2020.
- Derived from this study: PubMed 31356470D'Arrigo S, Sandroni C, Cacciola S, Dell'Anna AM, Pittiruti M, Annetta MG, Colosimo C, Antonelli M. Are Peripherally Inserted Central Catheters Suitable for Cardiac Output Assessment With Transpulmonary Thermodilution? Crit Care Med. 2019 Oct;47(10):1356-1361. doi: 10.1097/CCM.0000000000003917.
- Individual participant dataSharing planned: Undecided
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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.
Massimo Antonelli, MD study chair
Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transpulmonary thermodilution in people with Peripherally Inserted Central Catheters and CVC, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 8 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 27 Jan 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 Italy. 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?
Cardiac Index comparison via PICC (time frame: One hour). 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 NCT03834675, which also lists 1 linked publication.
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 27 Jan 2020.