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Completed

NCT Number: NCT02501681

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

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.

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Key information

Conditions

Microcirculation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Centre Leeuwarden

Leeuwarden, 8901 BR, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cardiovascular surgery needed

Exclusion criteria

  • no informed consent

Treatment and study plan

priming solution during cardiovascular surgery

Other

Primary outcomes

  1. change in microvascular flow index (MFI)

    Time frame: 1 day

    hemodilution by the priming solutions in extracorporeal circulation affects the sublingual microcirculation

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Acronym: Acibadem

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2015
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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