Effect of Fluid Challenge on Glycocalyx

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891342
• Other study ID #: AZVCR 9307_1
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: August 2018

Study information

• Verified date: March 2019
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

Related Conditions & MeSH terms

• Anesthesia
• Endothelial Dysfunction
• Sepsis
• Septic Shock
• Shock, Septic
• Surgery

Intervention

Drug:
• Fluid bolus administration
Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.

Locations

Country	Name	City	State
Czechia	FN Plzen	Plzen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove	University Hospital Pilsen

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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