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The Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions

Sponsor
Medical Centre Leeuwarden (Other)
Overall Status
Completed
CT.gov ID
NCT02144298
Collaborator
(none)
20
Enrollment
1
Location
11.1
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to observe the perioperative course of sublingual microcirculatory alterations in patients undergoing coronary artery bypass grafting (CABG) using cold blood compared with cristalloid cardioplegia. Additionally the impact of changes in hemodynamic parameters, blood gas, laboratory findings and standart therapy for intra and early postoperative period was studied. Intubation time, ICU stay, hospital stay, ICU readmission, morbidity and mortality were recorded.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The microcirculatory measurements were obtained in both groups in the sublingual mucosa using Cytocam imaging. The probe was handheld. Different precautions were taken and steps followed to obtain images of adequate quality and to ensure good reproducibility.

    Images were made after induction of anesthesia (t0), before CBP 5 minutes after heparine (t1), 5 minutes after CBP beginning (t2), during CBP 10 minutes after crossclamp beginning (t3), after crossclamp ending when heart begins to beat (t4), after CBP 10 minutes after protamine (t5).

    Additional images were made before (tc0) and after (tc1) vasoactive medication; before (tv0) and after (tv1) volume administration; before (tb0) and after (tb1) blood administration, (FFP, PLT).

    At each timepoint adequate focus depth and contrast were noticed. Three steady images of 6 seconds were acquired and recorded on a device controller based on a powerful medical grade computer which is used for image storage and analysis.

    Additionally macrocirculatory measurements were obtained at the same timepoints. Hemodynamic variables, temperature, blood gas, INVOS, StO2, laboratory findings and standart therapy were recorded. Additionally intubation time, ICU stay, hospital stay, ICU readmission, morbidity and mortality were studied.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Perioperative Course of Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions: Cold Blood Compared With Cristalloid Cardioplegia
    Study Start Date :
    Mar 1, 2014
    Actual Primary Completion Date :
    Nov 1, 2014
    Actual Study Completion Date :
    Feb 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    cold blood cardioplegia

    observe the perioperative course of sublingual microcirculatory alterations in patients undergoing coronary artery bypass grafting (CABG) using cold blood cardioplegia.
    cristalloid cardioplegia

    observe the perioperative course of sublingual microcirculatory alterations in patients undergoing coronary artery bypass grafting (CABG) using cristalloid cardioplegia.

    Outcome Measures

    Primary Outcome Measures

    1. functional capillary density [moment of measurement]

      functional capillary density is expected to be lower in the cryaloide group

    Secondary Outcome Measures

    1. percentage perfused density [time of measurement]

      a higher percentage of perfused vessel density is expected in the blood group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients undergoing coronary artery bypass grafting (CABG)
    Exclusion Criteria:

    • previous heart and oral surgery

    • age below 18 years,

    • emergency surgery

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Acıbadem University Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Medical Centre Leeuwarden

    Investigators

    • Principal Investigator: Can Ince, Prof, Medical Centre Amsterdam

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matty Koopmans, MSc, Medical Centre Leeuwarden
    ClinicalTrials.gov Identifier:
    NCT02144298
    Other Study ID Numbers:
    • ATADEK 2013-540
    First Posted:
    May 21, 2014
    Last Update Posted:
    Feb 13, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Matty Koopmans, MSc, Medical Centre Leeuwarden
    microcirculation
    coronary artery bypass grafting
    cold blood cardioplegia
    cristalloid cardioplegia

    Study Results

    No Results Posted as of Feb 13, 2015