- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02501681
Evaluation of Different Priming Solutions Effects on Microcirculation, Oxidative Stress and Morbidity in Cardiovascular Surgery Patients (Acibadem)
August 18, 2015 updated by: Matty Koopmans, Medical Centre Leeuwarden
Single-centre prospective randomized study will be included the patients who undergo elective cardiovascular surgery.
Preoperative fluid deficit will be calculated by the formula as starvation period X 4 X weight.
Patients will be divided into two groups: Group A (n=20); crystalloid as priming solution used in patients, Group B (n=20); colloids as priming solution used in patients.
In addition to priming solutions, extracorporeal pump will be filled with 150 mL of Mannitol, 60 mL of NaHCO3 and 10000 IU Insulin.
Standard anesthesia protocol will be administered to all patients.
Ringer's Lactate will be given at first 30 minute after induction.
Ringer's Lactate as fluid maintenance will be administered at a rate of 100 mL/h except in extracorporeal circulation.
Goal-directed fluid management will be performed by PVI (Pleth Variability Index).
Cut off level of PVI will be accepted %15.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For integrative investigation of the effects of priming solution and postoperative fluid management on the complex interrelation between microcirculation and reactive oxygen species; sublingual microcirculation using microcirculation imaging system (IDF, Cytocam, NL) will be displayed and measure ekstra vascular lung water (EVLW) using PiCCO and plasma levels of oxidative stress markers will be measured.
Sublingual tissue microcirculation will be evaluated in all patients at different time points as before induction (T0), after induction (T1), before cross clamping-hypothermic period (T2), after cross clamping (T3), before end of pump (normothermic period, heating) (T4), acceptance to intensive care unit (T5), third hour after surgery (T6) and twenty forth hour after surgery (T7).
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leeuwarden, Netherlands, 8901 BR
- Medical Centre Leeuwarden
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- cardiovascular surgery needed
Exclusion Criteria:
- no informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: crystalloid
Group A (n=20); crystalloid as priming solution used in patients,
|
|
Active Comparator: colloid
Group B (n=20); colloids as priming solution used in patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in microvascular flow index (MFI)
Time Frame: 1 day
|
hemodilution by the priming solutions in extracorporeal circulation affects the sublingual microcirculation
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
difference in MFI
Time Frame: 1 day
|
differences can be detected in the microcirculatory response to crystaloid priming in relation to colloid (starch) priming.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
July 13, 2015
First Submitted That Met QC Criteria
July 15, 2015
First Posted (Estimate)
July 17, 2015
Study Record Updates
Last Update Posted (Estimate)
August 19, 2015
Last Update Submitted That Met QC Criteria
August 18, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- Atadek 2014-723
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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