Comparing of Two Regimes (Fast and Slow) of Fluid Challenge on Glycocalyx Assessed by Perfused Boundary Region in Septic and Elective Major Surgical Patients
Overview
- Phase
- Not Applicable
- Intervention
- Fluid bolus administration
- Conditions
- Anesthesia
- Sponsor
- University Hospital Hradec Kralove
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Influence of balanced crystalloid infusion time on endothelial glycocalyx
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Interventional study comparing effect of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery on glycocalyx by using perfused Boundary Region in sublingual microcirculation.
Detailed Description
Effect of two regimes of fluid challenge on GCX in patients with sepsis and during elective surgery under general anesthesia. Hypothesis to be tested: Administration of 500 ml of balanced solution as a bolus impairs GCX more than prolonged administration. The aim of the study: Comparison of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery. Type of the study: Open, randomized, interventional. Subjects: Part A: Patients with sepsis within 48 hours before admission to ICU requiring fluid challenge based on clinical or echocardiographic assessment. Part B: Patients during major elective surgery requiring fluid challenge based on clinical or echocardiographic assessment. Sample size calculation (based on expected difference in PRB, alpha error I =0,05 and study power = 0,99) = 52 patients. Investigators plan enrolment of 60 patients for each part, totally 120 patients. Intervention: * 500 ml of balanced crystalloid solution within 5 minutes (group "fast") * 500 ml of balanced crystalloid solution within 30 minutes (group "slow") Data to be recorded and analysed: Demographics, severity score, fluid response assessment, sublingual microcirculation by SDF imaging will be recorded at time points: baseline, after intervention, after 60 minutes, after 120 minutes, plasma syndecan-1 will be analysed before intervention and 120 minutes thereafter, microcirculatory data and Perfused Boundary Region.
Investigators
Vladimir Cerny
Principal Investigator
University Hospital Hradec Kralove
Eligibility Criteria
Inclusion Criteria
- •arm A: age over 18, diagnosis sepsis, fluid bolus administration indicated, arm B: age 18-70, ASA status I-III, major surgery
Exclusion Criteria
- Not provided
Arms & Interventions
Patients with sepsis/septic shock
Comaprison of fast or slow fluid bolus administration in patients with sepsis/septic shock 48hours before admission to ICU requiring fluid challenge as assessed by clinical examination
Intervention: Fluid bolus administration
Major surgical patients
Comaprison of fast or slow fluid bolus administration in patients undergoing major surgery requiring fluid challenge as assessed by clinical examination
Intervention: Fluid bolus administration
Outcomes
Primary Outcomes
Influence of balanced crystalloid infusion time on endothelial glycocalyx
Time Frame: baseline and at 20, 40, 60 and 120 minutes
Change in the endothelial glycocalyx thickness by PBR method