Clinical trial NCT03799133: Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery
Official title: Safety and Efficacy of the Gastric Reactance (XL) in the Prediction of Morbimortality in Patients Post-operated of Elective Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Failure
Ventricular Dysfunction
Valvular Heart Disease
Keywords: gastric reactance
elective cardiac surgery
morbimortality
APACHE II
STS
SOFA
EUROSCORE II
Lead sponsor: Critical Perfusion Inc.
Sponsor class: INDUSTRY
Collaborators: name: Instituto Nacional de Cardiologia Ignacio Chavez
name: National Council of Science and Technology, Mexico
name: Gerbera Capital
name: Alandra Medical SAPI de CV
First posted: 2019-01-10
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Eligible patients will be placed the Florence catheter.
Primary purpose: SCREENING

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between gastric reactance (XL) and morbimortality and risk predictors
timeFrame: 72 hours
measure: Sensibility and specificity of the collected variables
timeFrame: 72 hours
measure: Adverse events tracing with the use of Florence catheter
timeFrame: 30 days
Secondary outcomes:
measure: Correlations between XL measurements and medication
timeFrame: 72 hours
measure: Correlations between laboratory parameters and XL
timeFrame: 72 hours
measure: Usability of Florence device in a real environment.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Cardiología Ignacio Chávez
state: Ciudad De México
Study officials:
affiliation: Instituto Nacional de Cardiologia Ignacio Chavez
name: Rolando J. Álvarez Álvarez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alandra Medical SAPI de CV
name: Montserrat Godínez, MSc
role: STUDY_DIRECTOR
References: