Effect of Fluid Challenge on Glycocalyx

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock; Surgery; Endothelial Dysfunction; Anesthesia
• Intervention / Treatment: Drug: Fluid bolus administration

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Plzen, Czechia
    • FN Plzen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Fluid bolus administration; Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.; Other Names: Fluid challenge
Experimental: Major surgical patients; 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; Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.; 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

Collaborators and Investigators

• Sponsor: University Hospital Hradec Kralove
• Collaborators: University Hospital Pilsen
• Investigators: Principal Investigator: Jan Benes, Assoc.Prof., Charles University hospital in Plzen, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: AZVCR 9307_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED