NCT03799133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

December 20, 2018

Last Update Submit

January 22, 2020

Conditions

Cardiac FailureVentricular DysfunctionValvular Heart Disease

Keywords

gastric reactanceelective cardiac surgerymorbimortalityAPACHE IISTSSOFAEUROSCORE II

Outcome Measures

Primary Outcomes (3)

  • 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

  • Sensibility and specificity of the collected variables

    ROC curves will be calculated to determine sensibility and specificity of the variables.

    72 hours

  • Adverse events tracing with the use of Florence catheter

    Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.

    30 days

Secondary Outcomes (3)

  • Correlations between XL measurements and medication

    72 hours

  • Correlations between laboratory parameters and XL

    72 hours

  • Usability of Florence device in a real environment.

    72 hours

Study Arms (1)

Patients with Florence device

EXPERIMENTAL

Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend.

Device: Florence device

Interventions

Florence deviceDEVICE

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

Also known as: ISMO, Gastric Impedance Spectrometer System
Patients with Florence device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cardiología Ignacio Chávez

Tlalpan, Mexico City, 14080, Mexico

Location

Related Links

MeSH Terms

Conditions

Heart FailureVentricular DysfunctionHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Rolando J. Álvarez Álvarez, MD

    Instituto Nacional de Cardiologia Ignacio Chavez

    PRINCIPAL INVESTIGATOR

  • Montserrat Godínez, MSc

    Alandra Medical SAPI de CV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Eligible patients will be placed the Florence catheter.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

January 10, 2019

Study Start

September 26, 2018

Primary Completion

December 28, 2019

Study Completion

December 28, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers.

Locations

ME(1)