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Clinical Trials/NCT02144298
NCT02144298
Completed
Not Applicable

The Perioperative Course of Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions: Cold Blood Compared With Cristalloid Cardioplegia

Medical Centre Leeuwarden1 site in 1 country20 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Microcirculatory Alterations
Sponsor
Medical Centre Leeuwarden
Enrollment
20
Locations
1
Primary Endpoint
functional capillary density
Status
Completed
Last Updated
11 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
February 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical Centre Leeuwarden
Responsible Party
Principal Investigator
Principal Investigator

Matty Koopmans

MSc

Medical Centre Leeuwarden

Eligibility Criteria

Inclusion Criteria

  • patients undergoing coronary artery bypass grafting (CABG)

Exclusion Criteria

  • previous heart and oral surgery
  • age below 18 years,
  • emergency surgery
  • pregnancy

Outcomes

Primary Outcomes

functional capillary density

Time Frame: moment of measurement

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

Secondary Outcomes

  • percentage perfused density(time of measurement)

Study Sites (1)

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