Oncologic High-risk SurgeryThermoD-PACNCT02063009
Measurement of Cardiac Index Using an Implanted Central Venous Access Port in Patients Scheduled for Oncologic High-risk Surgery
An observational study of Oncologic High-risk Surgery, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. We currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic High-risk Surgery
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Jan 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for oncologic high-risk surgery
Who may be able to join
- presence of port
- scheduled surgery with perioperative optimization requirement according to the local hemodynamic protocol
- oral consent of the patient after oral and written information
Who cannot join
- age inferior to 18
- Contraindication or failure to the insertion of the CVC
- Contraindication to the use of the port : local or general infection suspected or proved, absence of blood backflow
Trial locations and contacts
1 site in 1 country.
France1 site
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
About this study
Official title: Measurement of Cardiac Index by Transpulmonary Thermodilution Using an Implanted Central Venous Access Port: a Prospective Study in Patients Scheduled for Oncologic High-risk Surgery
Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. We currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. We chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Germany). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique.
In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.
Read the detailed description
The aim of this study was to assess whether measurement of the CI by TPTD was possible and reliable via the port. We conducted a prospective study comparing the measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.
- Conditions
- Oncologic High-risk Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients scheduled for oncologic high-risk surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the reliability of the measurement of the variations of the CI during fluid challenge
Measurements will be realized as described:
- hourly: TPTD will be realized to calibrate the measurement of CI
- Before and after fluid challenge (250 ml of colloid when hemodynamic indicators will be in favour of hypovolemia (pulse pressure variation (PPV) > 15% and variation of CI > 10%)
Measured: measurement of the CI hourly, up to 3 hours by TPTD before and after fluid challenge via the port versus the CVC.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJan 2013
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 Oncologic High-risk SurgeryStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Eghiaian, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063009
- Sponsor's protocol ID
- 2011-A00003-40
- Other IDs
- 2012/1836
- Acronym
- ThermoD-PAC
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Suria S, Wyniecki A, Eghiaian A, Monnet X, Weil G. Measurement of cardiac index by transpulmonary thermodilution using an implanted central venous access port: a prospective study in patients scheduled for oncologic high-risk surgery. PLoS One. 2014 Aug 19;9(8):e104369. doi: 10.1371/journal.pone.0104369. eCollection 2014.
PubMed 25136951
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Cardiac Index by Transpulmonary Thermodilution Using an Implanted Central Venous Access Port: a Prospective Study in Patients Scheduled for Oncologic High-risk Surgery
- ClinicalTrials.gov ID
- NCT02063009
- Acronym / sponsor ID
- ThermoD-PAC / 2011-A00003-40
- Conditions
- Oncologic High-risk Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Feb 2014 (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.
Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. We currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. We chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Germany). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique.
In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.
Detailed description
The aim of this study was to assess whether measurement of the CI by TPTD was possible and reliable via the port. We conducted a prospective study comparing the measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients scheduled for oncologic high-risk surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for oncologic high-risk surgery
Key inclusion criteria (3 listed)
- presence of port
- scheduled surgery with perioperative optimization requirement according to the local hemodynamic protocol
- oral consent of the patient after oral and written information
Key exclusion criteria (3 listed)
- age inferior to 18
- Contraindication or failure to the insertion of the CVC
- Contraindication to the use of the port : local or general infection suspected or proved, absence of blood backflow
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimation of the reliability of the measurement of the variations of the CI during fluid challenge
Time frame: measurement of the CI hourly, up to 3 hours by TPTD before and after fluid challenge via the port versus the CVC.
Measurements will be realized as described: * hourly: TPTD will be realized to calibrate the measurement of CI * Before and after fluid challenge (250 ml of colloid when hemodynamic indicators will be in favour of hypovolemia (pulse pressure variation (PPV) > 15% and variation of CI > 10%)
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 14 Feb 2014.
- Derived from this study: PubMed 25136951Suria S, Wyniecki A, Eghiaian A, Monnet X, Weil G. Measurement of cardiac index by transpulmonary thermodilution using an implanted central venous access port: a prospective study in patients scheduled for oncologic high-risk surgery. PLoS One. 2014 Aug 19;9(8):e104369. doi: 10.1371/journal.pone.0104369. eCollection 2014.
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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.
Alexandre Eghiaian, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
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 Oncologic High-risk Surgery, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 3 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 14 Feb 2014. 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 France. 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?
Estimation of the reliability of the measurement of the variations of the CI during fluid challenge (time frame: measurement of the CI hourly, up to 3 hours by TPTD before and after fluid challenge via the port versus the CVC.). 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 NCT02063009, 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 14 Feb 2014.