Clinical trial NCT02144298: The Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions
Official title: The Perioperative Course of Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions: Cold Blood Compared With Cristalloid Cardioplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microcirculatory Alterations
Keywords: microcirculation
coronary artery bypass grafting
cold blood cardioplegia
cristalloid cardioplegia
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: of patients undergoing coronary artery bypass grafting (CABG) using cristalloid (n=10) or cold blood (n=10) cardioplegia

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.

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

Primary outcomes:
measure: functional capillary density
timeFrame: moment of measurement
Secondary outcomes:
measure: percentage perfused density
timeFrame: time of measurement
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University Hospital
Study officials:
affiliation: Medical Centre Amsterdam
name: Can Ince, Prof
role: PRINCIPAL_INVESTIGATOR
References: