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

NCT03799133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-01-23

No results posted yet for this study

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.

Conditions

  • Cardiac Failure
  • Ventricular Dysfunction
  • Valvular Heart Disease

Interventions

DEVICE

Florence device

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

Sponsors & Collaborators

  • Instituto Nacional de Cardiologia Ignacio Chavez

    collaborator OTHER

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Gerbera Capital

    collaborator OTHER

  • Alandra Medical SAPI de CV

    collaborator INDUSTRY

  • Critical Perfusion Inc.

    lead INDUSTRY

Principal Investigators

  • Rolando J. Álvarez Álvarez, MD · Instituto Nacional de Cardiologia Ignacio Chavez

  • Montserrat Godínez, MSc · Alandra Medical SAPI de CV

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2019-12-28
Completion
2019-12-28

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03799133 on ClinicalTrials.gov