Peripherally Inserted Central CathetersNCT04241926
Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic Measurement by Transpulmonary Thermodilution.
A study testing transpolmonary thermodilution in people with Peripherally Inserted Central Catheters and Centrally Inserted Central Catheter, 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 to 90 years
- Conditions the study is for
- Peripherally Inserted Central Catheters, Centrally Inserted Central Catheter, Transpulmonary Thermodilution
- What is being tested?
- transpolmonary thermodilution
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2019to 29 Feb 2020
- 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 to 90 years
- 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.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italia, 00168
About this study
Official title: Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic
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 the investigators try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.
- Conditions
- Peripherally Inserted Central Catheters, Centrally Inserted Central Catheter, Transpulmonary Thermodilution, Hemodynamic Monitoring
- Being tested
- transpolmonary thermodilution
- Keywords
- PICC, CICC, Cardiac output, shock
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transpolmonary thermodilutionDiagnostic test
Thermodilution was attempted via PICC and via CICC in the same patient
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 of single-lumen 5Fr PICCs to CICC
Comparison of single-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output
Measured: one hour
Comparison of triple-lumen 6Fr PICCs to CICC
Comparison of triple-lumen 6 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 posted27 Jan 2020
- Study start1 May 2019
- Primary completion9 Feb 2020
- Study completion29 Feb 2020
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
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Antonio Maria Dell Anna, Sofia Cacciola, Claudio Sandroni, Giulia Chiuri, Mauro Pittiruti, Cesare Colosimo, Maria Giuseppina Annetta, 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
- NCT04241926
- Sponsor's protocol ID
- PICC 5Fr and 6Fr-CICC for TPTD
- Status last verified
- Jul 2020
- First submitted
- 22 Jan 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Arrigo S, Sandroni C, Cacciola S, Dell'Anna AM, Pittiruti M, Annetta MG, Colosimo C, Antonelli M. Are single-lumen 5Fr and triple-lumen 6Fr PICCs suitable for hemodynamic assessment by trans-pulmonary thermodilution? A pilot study. Ann Intensive Care. 2020 Dec 7;10(1):165. doi: 10.1186/s13613-020-00785-2.
PubMed 33284392
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic
- ClinicalTrials.gov ID
- NCT04241926
- Acronym / sponsor ID
- PICC 5Fr and 6Fr-CICC for TPTD
- Conditions
- Peripherally Inserted Central Catheters, Centrally Inserted Central Catheter, Transpulmonary Thermodilution, Hemodynamic Monitoring
- Keywords
- PICC, CICC, Cardiac output, shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Antonio Maria Dell Anna, Sofia Cacciola, Claudio Sandroni, Giulia Chiuri, Mauro Pittiruti, Cesare Colosimo, Maria Giuseppina Annetta, Antonelli, Massimo, M.D.
- Study start
- 1 May 2019 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 27 Jan 2020 (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 the investigators 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 to 90 years
- 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 |
|---|---|---|
| transpolmonary thermodilutionThermodilution was attempted via PICC and via CICC in the same patient | 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 of single-lumen 5Fr PICCs to CICC
Time frame: one hour
Comparison of triple-lumen 6Fr 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 23 Jul 2020.
- Derived from this study: PubMed 33284392D'Arrigo S, Sandroni C, Cacciola S, Dell'Anna AM, Pittiruti M, Annetta MG, Colosimo C, Antonelli M. Are single-lumen 5Fr and triple-lumen 6Fr PICCs suitable for hemodynamic assessment by trans-pulmonary thermodilution? A pilot study. Ann Intensive Care. 2020 Dec 7;10(1):165. doi: 10.1186/s13613-020-00785-2.
- 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.
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 transpolmonary thermodilution in people with Peripherally Inserted Central Catheters and Centrally Inserted Central Catheter, 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 23 Jul 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 NCT04241926, 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 23 Jul 2020.