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

Sponsor

Medical Centre Leeuwarden (Other)

Overall Status

Completed

CT.gov ID

NCT02501681

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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).

Study Design

Study Type:

Interventional

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 :

Feb 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

change in microvascular flow index (MFI) [1 day]
hemodilution by the priming solutions in extracorporeal circulation affects the sublingual microcirculation

Secondary Outcome Measures

difference in MFI [1 day]
differences can be detected in the microcirculatory response to crystaloid priming in relation to colloid (starch) priming.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

cardiovascular surgery needed

Exclusion Criteria:

no informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Centre Leeuwarden	Leeuwarden		Netherlands	8901 BR

Sponsors and Collaborators

Medical Centre Leeuwarden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matty Koopmans, MSc, Medical Centre Leeuwarden

ClinicalTrials.gov Identifier:

NCT02501681

Other Study ID Numbers:

Atadek 2014-723

First Posted:

Jul 17, 2015

Last Update Posted:

Aug 19, 2015

Last Verified:

Aug 1, 2015

Keywords provided by Matty Koopmans, MSc, Medical Centre Leeuwarden

sublingual microcirculation

cardiovascular surgery

Study Results

No Results Posted as of Aug 19, 2015