Cardiac FailureNCT03799133
Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery
A study testing Florence device in people with Cardiac Failure and Ventricular Dysfunction, run by Critical Perfusion Inc. at 1 site in Mexico.
Trial summary
Evaluate the safety and effectiveness of the XL trend measured by Florence (Critical Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients post-operated of elective cardiovascular surgery. Hypothesis: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Failure, Ventricular Dysfunction, Valvular Heart Disease
- What is being tested?
- Florence device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteMexico
- Study dates
- 26 Sep 2018to 28 Dec 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
- Women and men within an age equal or greater than 18 years old.
- Subjects scheduled to an elective cardiac surgery for valvular surgery, revascularization or a combination of both.
- Subjects compliant with the indication to be placed a floating pulmonary artery catheter.
- Marks results previous to surgery: STS mortality risk equal or greater than 6% of the day before or Euro Score II with a mortality risk equal or greater than 6% or left ventricle ejection fraction (LVEF/FEVI) less than 45% (patients with cardiac failure or right ventricle dysfunction or a combination of both), tricuspid annular plane systolic excursion (TAPSE) less than 17 mm, peak systolic velocity of tricuspid lateral ring measured by Tissue Doppler (LVOT/TSVI) less than 0.1 m/s; patient with elective surgery of: aortic and mitral valve replacement or aortic and mitral valve replacement + tricuspid valve plasty or aortic valve replacement + mitral valve plasty or mitral valve replacement + tricuspid valve plasty or aortic, mitral and tricuspid valve replacement or aortic valve replacement + tricuspid valve plasty or double valve replacement (any combination) + revascularization or aortic valve replacement + revascularization + mitral valve plasty.
- Subject is not enrolled in another investigational protocol.
- Informed consent has been signed of acceptance by the subject before study procedures.
- Subject in sinus rhythm before surgery.
Who cannot join
- Subjects with records of recent digestive tube bleeding (last 30 days).
- Paraplegic or hemiplegic subjects.
- Subjects with congenital background (interauricular communication, ventricular atrial channel, coarctation of the aorta, persistent arterial duct, pulmonary stenosis, ventricular septal defect, tetralogy of fallot, total or partial anomalous pulmonary venous drainage, transposition of the great vessels, tricuspid atresia, arterial trunk, etc).
- Maxillofacial malformation.
- Catheter placement failure.
- Known pregnancy or discovered pregnancy after admission (before surgery).
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- Woman in breastfeeding period.
- Subjects not compliant with clinical indication of nasogastric catheter placement or contraindicated to place a nasogastric catheter.
- Subjects with an implanted pacemaker or permanent defibrillator.
- Medication supply that impedes contact between Florence catheter and the gastric mucosa (barrier effect) like sucralfate, aluminum hydroxide, bismuth subsalicylate, magaldrate, etc.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cardiología Ignacio Chávez
Tlalpan, Mexico City, 14080
About this study
Official title: Safety and Efficacy of the Gastric Reactance (XL) in the Prediction of Morbimortality in Patients Post-operated of Elective Cardiac Surgery
Evaluate the safety and effectiveness of the XL trend measured by Florence (Critical Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients post-operated of elective cardiovascular surgery.
Hypothesis: 1. The gastric reactance measurement (XL) correlates with the morbimortality (postoperatory shock, excessive bleeding, vasoplegic syndrome and death) and with the risk predictors (APACHE II, STS, SOFA, and EUROSCORE II) with patients post-operated of elective cardiac surgery. 2. It is possible to identify the cut-off point of the values of the gastric reactance (XL) as a predictive tool of morbimortality in patients post-operated of elective cardiac surgery. 3. The gastric reactance (XL) is a safe measurement to patients undergoing cardiac surgery.
Read the detailed description
A maximum of 35 patients with age greater or equal to 18 years with elective surgery (valvular surgery, revascularization, or a combination of both) that comply with the inclusion/exclusion criteria of this protocol will be enrolled.
Investigational device: Florence (Gastric Impedance Spectrometer System or ISMO). Comparative with Risk scales SOFA, APACHE II, STS, Euroscore II, hemodynamic variables, lactate and mixed venous saturation.
The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
- Being tested
- Florence device
- Keywords
- gastric reactance, elective cardiac surgery, morbimortality, APACHE II, STS, SOFA, EUROSCORE II
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florence deviceDevice
Also called ISMO, Gastric Impedance Spectrometer System
The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Florence device | Experimental | Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend. Receives: Device: Florence device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between gastric reactance (XL) and morbimortality and risk predictors
Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting the risk scales, hemodynamic variables, lactate and mixed venous oxygen saturation, morbidity and mortality with central gastric reactance (XL).
Measured: 72 hours
Sensibility and specificity of the collected variables
ROC curves will be calculated to determine sensibility and specificity of the variables.
Measured: 72 hours
Adverse events tracing with the use of Florence catheter
Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.
Measured: 30 days
Secondary outcomes (3)
Correlations between XL measurements and medication
Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with amines, proton-pump inhibitors, and anesthesia medications.
Measured: 72 hours
Correlations between laboratory parameters and XL
Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with laboratory parameters.
Measured: 72 hours
Usability of Florence device in a real environment.
Questionnaire for the nurse and/or the physician regarding the use of Florence device at the Operating Room and Intensive Care Unit.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start26 Sep 2018
- Primary completion28 Dec 2019
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible patients will be placed the Florence catheter.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Critical Perfusion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Nacional de Cardiologia Ignacio Chavez, National Council of Science and Technology, Mexico, Gerbera Capital, Alandra Medical SAPI de CV
- Responsible party
- Sponsor
- Investigators
- Rolando J. Álvarez Álvarez, MD, Principal investigator, Instituto Nacional de Cardiologia Ignacio ChavezMontserrat Godínez, MSc, Study director, Alandra Medical SAPI de CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799133
- Sponsor's protocol ID
- ISM_VC_01_17
- Other IDs
- 17-1025
- Status last verified
- Jan 2020
- First submitted
- 20 Dec 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Gastric Reactance (XL) in the Prediction of Morbimortality in Patients Post-operated of Elective Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03799133
- Acronym / sponsor ID
- ISM_VC_01_17
- Keywords
- gastric reactance, elective cardiac surgery, morbimortality, APACHE II, STS, SOFA, EUROSCORE II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Critical Perfusion Inc.Industry (pharma, biotech, devices)
- Collaborators
- Instituto Nacional de Cardiologia Ignacio Chavez, National Council of Science and Technology, Mexico, Gerbera Capital, Alandra Medical SAPI de CV
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 10 Jan 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.
Evaluate the safety and effectiveness of the XL trend measured by Florence (Critical Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients post-operated of elective cardiovascular surgery.
Hypothesis: 1. The gastric reactance measurement (XL) correlates with the morbimortality (postoperatory shock, excessive bleeding, vasoplegic syndrome and death) and with the risk predictors (APACHE II, STS, SOFA, and EUROSCORE II) with patients post-operated of elective cardiac surgery. 2. It is possible to identify the cut-off point of the values of the gastric reactance (XL) as a predictive tool of morbimortality in patients post-operated of elective cardiac surgery. 3. The gastric reactance (XL) is a safe measurement to patients undergoing cardiac surgery.
Detailed description
A maximum of 35 patients with age greater or equal to 18 years with elective surgery (valvular surgery, revascularization, or a combination of both) that comply with the inclusion/exclusion criteria of this protocol will be enrolled.
Investigational device: Florence (Gastric Impedance Spectrometer System or ISMO). Comparative with Risk scales SOFA, APACHE II, STS, Euroscore II, hemodynamic variables, lactate and mixed venous saturation.
The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible patients will be placed the Florence catheter.
| Arm | Type | Receives |
|---|---|---|
| Patients with Florence device | Experimental | Device: Florence devicePatients with the Florence catheter placed and connected to the Florence monitor to measure XL trend. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women and men within an age equal or greater than 18 years old.
- Subjects scheduled to an elective cardiac surgery for valvular surgery, revascularization or a combination of both.
- Subjects compliant with the indication to be placed a floating pulmonary artery catheter.
- Marks results previous to surgery: STS mortality risk equal or greater than 6% of the day before or Euro Score II with a mortality risk equal or greater than 6% or left ventricle ejection fraction (LVEF/FEVI) less than 45% (patients with cardiac failure or right ventricle dysfunction or a combination of both), tricuspid annular plane systolic excursion (TAPSE) less than 17 mm, peak systolic velocity of tricuspid lateral ring measured by Tissue Doppler (LVOT/TSVI) less than 0.1 m/s; patient with elective surgery of: aortic and mitral valve replacement or aortic and mitral valve replacement + tricuspid valve plasty or aortic valve replacement + mitral valve plasty or mitral valve replacement + tricuspid valve plasty or aortic, mitral and tricuspid valve replacement or aortic valve replacement + tricuspid valve plasty or double valve replacement (any combination) + revascularization or aortic valve replacement + revascularization + mitral valve plasty.
- Subject is not enrolled in another investigational protocol.
Key exclusion criteria (10 listed)
- Subjects with records of recent digestive tube bleeding (last 30 days).
- Paraplegic or hemiplegic subjects.
- Subjects with congenital background (interauricular communication, ventricular atrial channel, coarctation of the aorta, persistent arterial duct, pulmonary stenosis, ventricular septal defect, tetralogy of fallot, total or partial anomalous pulmonary venous drainage, transposition of the great vessels, tricuspid atresia, arterial trunk, etc).
- Maxillofacial malformation.
- Catheter placement failure.
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 |
|---|---|---|
| Florence deviceAlso: ISMO, Gastric Impedance Spectrometer SystemThe Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU. | Device | Patients with Florence device |
Primary outcome
Correlation between gastric reactance (XL) and morbimortality and risk predictors
Time frame: 72 hours
Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting the risk scales, hemodynamic variables, lactate and mixed venous oxygen saturation, morbidity and mortality with central gastric reactance (XL).
Sensibility and specificity of the collected variables
Time frame: 72 hours
ROC curves will be calculated to determine sensibility and specificity of the variables.
Adverse events tracing with the use of Florence catheter
Time frame: 30 days
Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.
3 secondary outcomes
Correlations between XL measurements and medication
Time frame: 72 hours
Correlations between laboratory parameters and XL
Time frame: 72 hours
Usability of Florence device in a real environment.
Time frame: 72 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 23 Jan 2020.
- WHO Cardiovascular illness; 2015Link provided by the sponsor.
- Arias AS, Serrano MEB, Altamirano BD, Ortega MG, Gonzalez GG. Cardiovascular illness: first cause of morbility in a third level hospital. Cardiology Mexican Journal; 2016Link provided by the sponsor.
- Mittal R, Coopersmith CM. Redefining the gut as the motor of critical illness. Trends in molecular medicine. 2014 Apr;20:214-223Link provided by the sponsor.
- Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, et al. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Critical care medicine. 2013 Feb;41:580-637Link provided by the sponsor.
- Antonelli M, Levy M, Andrews PJD, Chastre J, Hudson LD, Manthous C, et al. Hemodynamic monitoring in shock and implications for management. International Consensus Conference, Paris, France, 27-28 April 2006. Intensive care medicine. 2007 Apr;33:575-590Link provided by the sponsor.
- Nieminen MS, Boehm M, Cowie MR, Drexler H, Filippatos GS, Jondeau G, et al. Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
Rolando J. Álvarez Álvarez, MD principal investigator
Instituto Nacional de Cardiologia Ignacio Chavez
Montserrat Godínez, MSc study director
Alandra Medical SAPI de CV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Florence device in people with Cardiac Failure and Ventricular Dysfunction, run by Critical Perfusion Inc. at 1 site in Mexico.
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 7 inclusion and 10 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 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 Mexico. 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?
Correlation between gastric reactance (XL) and morbimortality and risk predictors (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2020.