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

Microcirculation Clinical Trial

— Acibadem  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501681
• Other study ID #: Atadek 2014-723
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2015
• Last updated: August 18, 2015
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• cardiovascular surgery needed

Exclusion Criteria:

• no informed consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Microcirculation

Intervention

Other:
• priming solution during cardiovascular surgery

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in microvascular flow index (MFI)	hemodilution by the priming solutions in extracorporeal circulation affects the sublingual microcirculation	1 day	No
Secondary	difference in MFI	differences can be detected in the microcirculatory response to crystaloid priming in relation to colloid (starch) priming.	1 day	No