Effect of Fluid Challenge on Glycocalyx

Not Applicable

Completed

• Conditions: Endothelial Dysfunction; Sepsis; Septic Shock; Surgery; Anesthesia
• Interventions: Drug: Fluid bolus administration

• Registration Number: NCT03891342
• Lead Sponsor: University Hospital Hradec Kralove

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2017-10-24
• Primary Completion: 2018-07
• Study Completion: 2018-08
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-25
• Last Update Submitted: 2019-03-25
• Study First Posted: 2019-03-27
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Major surgical patients	Fluid bolus administration	Comaprison of fast or slow fluid bolus administration in patients undergoing major surgery requiring fluid challenge as assessed by clinical examination
Patients with sepsis/septic shock	Fluid bolus administration	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

Primary Outcome Measures

Name	Time	Method
Influence of balanced crystalloid infusion time on endothelial glycocalyx	baseline and at 20, 40, 60 and 120 minutes	Change in the endothelial glycocalyx thickness by PBR method

Trial Locations

Locations (1)

FN Plzen; 🇨🇿 Plzen, Czechia