Effect of Fluid Challenge on Glycocalyx

Study 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.

Official Title
-----------------
Comparing of Two Regimes (Fast and Slow) of Fluid Challenge on Glycocalyx Assessed by Perfused Boundary Region in Septic and Elective Major Surgical Patients

Conditions
-----------------
Anesthesia, Endothelial Dysfunction, Sepsis, Septic Shock, Surgery

Intervention / Treatment
-----------------
* Drug: Fluid bolus administration


Participation Criteria
=================
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: none.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with sepsis/septic shock<br>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 | Drug: Fluid bolus administration<br>* Fluid bolus administration either fast in 5 minutes or slow in 30minutes.<br>* Other names: Fluid challenge;|
| Experimental: Major surgical patients<br>Comaprison of fast or slow fluid bolus administration in patients undergoing major surgery requiring fluid challenge as assessed by clinical examination | Drug: Fluid bolus administration<br>* Fluid bolus administration either fast in 5 minutes or slow in 30minutes.<br>* Other names: Fluid challenge;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of balanced crystalloid infusion time on endothelial glycocalyx | Change in the endothelial glycocalyx thickness by PBR method | baseline and at 20, 40, 60 and 120 minutes |