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

Phase 4

Completed

• Conditions: Microcirculation
• Interventions: Other: priming solution during cardiovascular surgery

• Registration Number: NCT02501681
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• cardiovascular surgery needed

Exclusion Criteria

• no informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
crystalloid	priming solution during cardiovascular surgery	Group A (n=20); crystalloid as priming solution used in patients,
colloid	priming solution during cardiovascular surgery	Group B (n=20); colloids as priming solution used in patients

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical Centre Leeuwarden; 🇳🇱 Leeuwarden, Netherlands