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

Sponsors

Lead Sponsor: University Hospital Hradec Kralove

Collaborator: University Hospital Pilsen

Source 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.

Overall Status Completed
Start Date 2016-02-01
Completion Date 2018-08-01
Primary Completion Date 2018-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Influence of balanced crystalloid infusion time on endothelial glycocalyx baseline and at 20, 40, 60 and 120 minutes
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fluid bolus administration

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

Other Name: Fluid challenge

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jan Benes, Assoc.Prof. Principal Investigator Charles University hospital in Plzen, Czech Republic
Location
Facility: FN Plzen
Location Countries

Czechia

Verification Date

2019-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University Hospital Hradec Kralove

Investigator Full Name: Vladimir Cerny

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Patients with sepsis/septic shock

Type: Experimental

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

Label: Major surgical patients

Type: Experimental

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov

Clinical Research News