Acute Circulatory FailureTCCONCT03694717
Time Course Evolution of Cardiac Output
An observational study of Acute Circulatory Failure, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil.
Trial summary
Fluid expansion is the first therapeutic option in patients presenting acute circulatory failure but the duration of its hemodynamic effects (persistency and time of maximal increase in cardiac output) is unknown. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Circulatory Failure
- What is being tested?
- Saline Solution for Injection
- Type of treatment
- Injection or infusion
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2016to 31 May 2018
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted in the intensive care unit receiving mechanical ventilation and presenting an acute circulatory failure.
Who may be able to join
- acute circulatory failure (infusion of norepinephrine)
- invasive mechanical ventilation through an endotracheal tube
- decision of fluid expansion
- Non inclusion Criteria:
- extracorporeal membranous oxygenation (ECMO)
- active bleeding
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- continuous renal replacement therapy with weight loss
- administration of diuretics within the past six hours
- decision of therapeutic limitation,
- age under eighteen years
Who cannot join
- hemodynamic instability after fluid expansion (mean arterial pressure < 65mmHg)
About this study
Official title: Time Course Evolution of Cardiac Output in Critically Ill Patients After a Fluid Expansion
Fluid expansion is the first therapeutic option in patients presenting acute circulatory failure but the duration of its hemodynamic effects (persistency and time of maximal increase in cardiac output) is unknown.
This study is seeking to describe in critically ill patients, the time course evolution of cardiac output over a 2-hours period after a fluid expansion.
Read more
The objectives are:
- to identify patterns of fluid responsiveness
- to determine the time when the maximal increase in cardiac output occurs during and a after fluid expansion
- to compare patients' characteristics between patterns
Patients with acute circulatory failure will be recruited as soon as a fluid expansion will be decided by the physician in charge and the effects of fluid expansion on hemodynamic indices (cardiac output, arterial pressure) will be continuously recorded through a transpulmonary thermodilution device over a 2-hours period.
No changes in ventilatory settings nor vasopressors or sedatives will be allowed during the study.
Patients will be categorized into patterns according to the changes in cardiac output after fluid expansion and their characteristics will be compared.
Read the detailed description
The study will be conducted in four medico-surgical ICUs in France between April 2016 and April 2018.
Since fluid challenge and invasive monitoring by thermodilution device is standard of care for septic shock management, the institutional review board waived patient consent. All patients and/or their next of kind will receive written information.
Eligible patients will have to present an acute circulatory failure for whom the physician in charge will decide to start a fluid expansion.
Hemodynamic variables will be obtained through transpulmonary thermodilution and pulse contour analysis (PICCO2 device, Pulsion Germany).
Fluid expansion will consist in the infusion of 500 ml of saline through a central venous catheter in a standardized 10-minutes period. The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.
Fluid responsiveness will be defined by an increase in cardiac output over 15-per-cent from baseline (before fluid expansion).
Study design:
At time of decision to make the fluid expansion, a calibration of the PICCO2 device will be performed and a first set of hemodynamic measurements will be collected (cardiac output, cardiac function index, extravascular lung water, permeability vascular pulmonary index, global end diastolic volume, arterial pressure, heart rate).
Then, fluid expansion will be administrated in less than 10 minutes. From the start of fluid expansion to the end of the two-hours period ot time, pulse contour cardiac output and arterial pressure will be continuously recorded.
During the whole two hours period, no change in vasopressor dosage nor mechanical ventilation settings will be allowed.
In case of hemodynamic instability, defined by a mean arterial pressure under 65mmHg, a new fluid expansion could be realized. In this last case, the protocol will start again from the beginning.
- Conditions
- Acute Circulatory Failure
- Being tested
- Saline Solution for Injection
- Keywords
- shock, fluid expansion, fluid responsiveness
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Solution for InjectionDrug
The fluid expansion will consist in a less than 10 min infusion of 500 milliliters of saline through a central venous catheter (jugular). The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Patients | The patients will receive a 500 ml fluid expansion over a standardized 10 minutes period Receives: Drug: Saline Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac output during fluid expansion
Difference between maximal cardiac output during fluid expansion and baseline
Measured: 10 minutes
Secondary outcomes (1)
Change in cardiac output after fluid expansion
Change in cardiac output after fluid expansion
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start15 Apr 2016
- Primary completion15 May 2018
- Study completion31 May 2018
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 Acute Circulatory FailureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Dres, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694717
- Sponsor's protocol ID
- ADOREPS
- Acronym
- TCCO
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nunes TS, Ladeira RT, Bafi AT, de Azevedo LC, Machado FR, Freitas FG. Duration of hemodynamic effects of crystalloids in patients with circulatory shock after initial resuscitation. Ann Intensive Care. 2014 Aug 1;4:25. doi: 10.1186/s13613-014-0025-9. eCollection 2014.
PubMed 25593742
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course Evolution of Cardiac Output in Critically Ill Patients After a Fluid Expansion
- ClinicalTrials.gov ID
- NCT03694717
- Acronym / sponsor ID
- TCCO / ADOREPS
- Conditions
- Acute Circulatory Failure
- Keywords
- shock, fluid expansion, fluid responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 3 Oct 2018 (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.
Fluid expansion is the first therapeutic option in patients presenting acute circulatory failure but the duration of its hemodynamic effects (persistency and time of maximal increase in cardiac output) is unknown.
This study is seeking to describe in critically ill patients, the time course evolution of cardiac output over a 2-hours period after a fluid expansion.
The objectives are:
- to identify patterns of fluid responsiveness
- to determine the time when the maximal increase in cardiac output occurs during and a after fluid expansion
- to compare patients' characteristics between patterns
Patients with acute circulatory failure will be recruited as soon as a fluid expansion will be decided by the physician in charge and the effects of fluid expansion on hemodynamic indices (cardiac output, arterial pressure) will be continuously recorded through a transpulmonary thermodilution device over a 2-hours period.
No changes in ventilatory settings nor vasopressors or sedatives will be allowed during the study.
Patients will be categorized into patterns according to the changes in cardiac output after fluid expansion and their characteristics will be compared.
Detailed description
The study will be conducted in four medico-surgical ICUs in France between April 2016 and April 2018.
Since fluid challenge and invasive monitoring by thermodilution device is standard of care for septic shock management, the institutional review board waived patient consent. All patients and/or their next of kind will receive written information.
Eligible patients will have to present an acute circulatory failure for whom the physician in charge will decide to start a fluid expansion.
Hemodynamic variables will be obtained through transpulmonary thermodilution and pulse contour analysis (PICCO2 device, Pulsion Germany).
Fluid expansion will consist in the infusion of 500 ml of saline through a central venous catheter in a standardized 10-minutes period. The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.
Fluid responsiveness will be defined by an increase in cardiac output over 15-per-cent from baseline (before fluid expansion).
Study design:
At time of decision to make the fluid expansion, a calibration of the PICCO2 device will be performed and a first set of hemodynamic measurements will be collected (cardiac output, cardiac function index, extravascular lung water, permeability vascular pulmonary index, global end diastolic volume, arterial pressure, heart rate).
Then, fluid expansion will be administrated in less than 10 minutes. From the start of fluid expansion to the end of the two-hours period ot time, pulse contour cardiac output and arterial pressure will be continuously recorded.
During the whole two hours period, no change in vasopressor dosage nor mechanical ventilation settings will be allowed.
In case of hemodynamic instability, defined by a mean arterial pressure under 65mmHg, a new fluid expansion could be realized. In this last case, the protocol will start again from the beginning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: Saline Solution for InjectionThe patients will receive a 500 ml fluid expansion over a standardized 10 minutes period |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted in the intensive care unit receiving mechanical ventilation and presenting an acute circulatory failure.
Key inclusion criteria (10 listed)
- acute circulatory failure (infusion of norepinephrine)
- invasive mechanical ventilation through an endotracheal tube
- decision of fluid expansion
- extracorporeal membranous oxygenation (ECMO)
- active bleeding
Key exclusion criteria (1 listed)
- hemodynamic instability after fluid expansion (mean arterial pressure < 65mmHg)
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 |
|---|---|---|
| Saline Solution for InjectionThe fluid expansion will consist in a less than 10 min infusion of 500 milliliters of saline through a central venous catheter (jugular). The duration of infusion will be controlled by an airbag pressurized at 300 mmHg. | Drug | Patients |
Primary outcome
Change in cardiac output during fluid expansion
Time frame: 10 minutes
Difference between maximal cardiac output during fluid expansion and baseline
1 secondary outcome
Change in cardiac output after fluid expansion
Time frame: 2 hours
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 4 Oct 2018.
- Results publication: PubMed 25593742Nunes TS, Ladeira RT, Bafi AT, de Azevedo LC, Machado FR, Freitas FG. Duration of hemodynamic effects of crystalloids in patients with circulatory shock after initial resuscitation. Ann Intensive Care. 2014 Aug 1;4:25. doi: 10.1186/s13613-014-0025-9. eCollection 2014.
- 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.
Martin Dres, MD, PhD principal investigator
APHP
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Circulatory Failure, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil.
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 10 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 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in cardiac output during fluid expansion (time frame: 10 minutes). 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 NCT03694717, 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 4 Oct 2018.