Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery
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| ClinicalTrials.gov Identifier: NCT03799133 |
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Recruitment Status :
Completed
First Posted : January 10, 2019
Last Update Posted : January 23, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Failure Ventricular Dysfunction Valvular Heart Disease | Device: Florence device | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 38 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Eligible patients will be placed the Florence catheter. |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | Safety and Efficacy of the Gastric Reactance (XL) in the Prediction of Morbimortality in Patients Post-operated of Elective Cardiac Surgery |
| Actual Study Start Date : | September 26, 2018 |
| Actual Primary Completion Date : | December 28, 2019 |
| Actual Study Completion Date : | December 28, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Patients with Florence device
Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend.
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Device: Florence device
The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
Other Names:
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- 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.
- Correlations between XL measurements and medication [ Time Frame: 72 hours ]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.
- Correlations between laboratory parameters and XL [ Time Frame: 72 hours ]Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with laboratory parameters.
- Usability of Florence device in a real environment. [ Time Frame: 72 hours ]Questionnaire for the nurse and/or the physician regarding the use of Florence device at the Operating Room and Intensive Care Unit.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799133
| Mexico | |
| Instituto Nacional de Cardiología Ignacio Chávez | |
| Tlalpan, Ciudad De México, Mexico, 14080 | |
| Principal Investigator: | Rolando J. Álvarez Álvarez, MD | Instituto Nacional de Cardiologia Ignacio Chavez | |
| Study Director: | Montserrat Godínez, MSc | Alandra Medical SAPI de CV |
| Responsible Party: | Critical Perfusion Inc. |
| ClinicalTrials.gov Identifier: | NCT03799133 |
| Other Study ID Numbers: |
ISM_VC_01_17 17-1025 ( Other Identifier: Instituto Nacional de Cardiología Ignacio Chávez ) |
| First Posted: | January 10, 2019 Key Record Dates |
| Last Update Posted: | January 23, 2020 |
| Last Verified: | January 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | There is no plan to make individual participant data (IPD) available to other researchers. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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gastric reactance elective cardiac surgery morbimortality APACHE II |
STS SOFA EUROSCORE II |
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Heart Diseases Ventricular Dysfunction Heart Valve Diseases Heart Failure Cardiovascular Diseases |