Microcirculatory AlterationsNCT02144298
The Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions
An observational study of Microcirculatory Alterations, run by Frisius Medisch Centrum at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microcirculatory Alterations
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: of patients undergoing coronary artery bypass grafting (CABG) using cristalloid (n=10) or cold blood (n=10) cardioplegia
Who may be able to join
- patients undergoing coronary artery bypass grafting (CABG)
Who cannot join
- previous heart and oral surgery
- age below 18 years,
- emergency surgery
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Perioperative Course of Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions: Cold Blood Compared With Cristalloid Cardioplegia
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.
Read the 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.
- Conditions
- Microcirculatory Alterations
- Keywords
- microcirculation, coronary artery bypass grafting, cold blood cardioplegia, cristalloid cardioplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional capillary density
functional capillary density is expected to be lower in the cryaloide group
Measured: moment of measurement
Secondary outcomes (1)
percentage perfused density
a higher percentage of perfused vessel density is expected in the blood group
Measured: time of measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcirculatory AlterationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matty Koopmans, Frisius Medisch Centrum
- Investigators
- Can Ince, Prof, Principal investigator, Medical Centre Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144298
- Sponsor's protocol ID
- ATADEK 2013-540
- Status last verified
- Feb 2015
- First submitted
- 19 May 2014
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perioperative Course of Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions: Cold Blood Compared With Cristalloid Cardioplegia
- ClinicalTrials.gov ID
- NCT02144298
- Acronym / sponsor ID
- ATADEK 2013-540
- Conditions
- Microcirculatory Alterations
- Keywords
- microcirculation, coronary artery bypass grafting, cold blood cardioplegia, cristalloid cardioplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- of patients undergoing coronary artery bypass grafting (CABG) using cristalloid (n=10) or cold blood (n=10) cardioplegia
Key inclusion criteria (1 listed)
- patients undergoing coronary artery bypass grafting (CABG)
Key exclusion criteria (4 listed)
- previous heart and oral surgery
- age below 18 years,
- emergency surgery
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
functional capillary density
Time frame: moment of measurement
functional capillary density is expected to be lower in the cryaloide group
1 secondary outcome
percentage perfused density
Time frame: time of measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Can Ince, Prof principal investigator
Medical Centre Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcirculatory Alterations, run by Frisius Medisch Centrum at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional capillary density (time frame: moment of measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.