Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery

Valvular Heart Disease Clinical Trial

Official title:

Safety and Efficacy of the Gastric Reactance (XL) in the Prediction of Morbimortality in Patients Post-operated of Elective Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799133
• Other study ID #: ISM_VC_01_17
• Secondary ID: 17-1025
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: December 28, 2019

Study information

• Verified date: January 2020
• Source: Critical Perfusion Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 28, 2019
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Valvular Heart Disease
• Ventricular Dysfunction

Intervention

Device:
• Florence device
The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiología Ignacio Chávez	Tlalpan	Ciudad De México

Sponsors (5)

Lead Sponsor	Collaborator
Critical Perfusion Inc.	Alandra Medical SAPI de CV, Gerbera Capital, Instituto Nacional de Cardiologia Ignacio Chavez, National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	72 hours
Primary	Sensibility and specificity of the collected variables	ROC curves will be calculated to determine sensibility and specificity of the variables.	72 hours
Primary	Adverse events tracing with the use of Florence catheter	Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.	30 days
Secondary	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.	72 hours
Secondary	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.	72 hours
Secondary	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.	72 hours

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