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Effect of Fluid Challenge on Glycocalyx

Primary Purpose

Anesthesia, Endothelial Dysfunction, Sepsis

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Fluid bolus administration
Sponsored by
University Hospital Hradec Kralove
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • FN Plzen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with sepsis/septic shock

Major surgical patients

Arm Description

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

Comaprison of fast or slow fluid bolus administration in patients undergoing major surgery requiring fluid challenge as assessed by clinical examination

Outcomes

Primary Outcome Measures

Influence of balanced crystalloid infusion time on endothelial glycocalyx
Change in the endothelial glycocalyx thickness by PBR method

Secondary Outcome Measures

Full Information

First Posted
October 24, 2017
Last Updated
March 25, 2019
Sponsor
University Hospital Hradec Kralove
Collaborators
University Hospital Pilsen
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1. Study Identification

Unique Protocol Identification Number
NCT03891342
Brief Title
Effect of Fluid Challenge on Glycocalyx
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove
Collaborators
University Hospital Pilsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Endothelial Dysfunction, Sepsis, Septic Shock, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with sepsis/septic shock
Arm Type
Experimental
Arm Description
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
Arm Title
Major surgical patients
Arm Type
Experimental
Arm Description
Comaprison of fast or slow fluid bolus administration in patients undergoing major surgery requiring fluid challenge as assessed by clinical examination
Intervention Type
Drug
Intervention Name(s)
Fluid bolus administration
Other Intervention Name(s)
Fluid challenge
Intervention Description
Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.
Primary Outcome Measure Information:
Title
Influence of balanced crystalloid infusion time on endothelial glycocalyx
Description
Change in the endothelial glycocalyx thickness by PBR method
Time Frame
baseline and at 20, 40, 60 and 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Benes, Assoc.Prof.
Organizational Affiliation
Charles University hospital in Plzen, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
FN Plzen
City
Plzen
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Fluid Challenge on Glycocalyx

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