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Evaluation of Different Priming Solutions Effects on Microcirculation, Oxidative Stress and Morbidity in Cardiovascular Surgery Patients (Acibadem)

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ClinicalTrials.gov Identifier: NCT02501681
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Matty Koopmans, Medical Centre Leeuwarden

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Microcirculation Other: priming solution during cardiovascular surgery Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Different Priming Solutions Effects on Microcirculation, Oxidative Stress and Morbidity in Cardiovascular Surgery Patients
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Active Comparator: crystalloid
Group A (n=20); crystalloid as priming solution used in patients,
Other: priming solution during cardiovascular surgery
Active Comparator: colloid
Group B (n=20); colloids as priming solution used in patients
Other: priming solution during cardiovascular surgery



Primary Outcome Measures :
  1. change in microvascular flow index (MFI) [ Time Frame: 1 day ]
    hemodilution by the priming solutions in extracorporeal circulation affects the sublingual microcirculation


Secondary Outcome Measures :
  1. difference in MFI [ Time Frame: 1 day ]
    differences can be detected in the microcirculatory response to crystaloid priming in relation to colloid (starch) priming.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cardiovascular surgery needed

Exclusion Criteria:

  • no informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501681


Locations
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Netherlands
Medical Centre Leeuwarden
Leeuwarden, Netherlands, 8901 BR
Sponsors and Collaborators
Medical Centre Leeuwarden
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Responsible Party: Matty Koopmans, MSc, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT02501681    
Other Study ID Numbers: Atadek 2014-723
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Keywords provided by Matty Koopmans, Medical Centre Leeuwarden:
sublingual microcirculation
cardiovascular surgery