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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03891342
Enrollment
120
Registered
2019-03-27
Start date
2016-02-29
Completion date
2018-08-31
Last updated
2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Endothelial Dysfunction, Sepsis, Septic Shock, Surgery

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.

Interventions

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

Sponsors

University Hospital Pilsen
CollaboratorOTHER
University Hospital Hradec Kralove
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Influence of balanced crystalloid infusion time on endothelial glycocalyxbaseline and at 20, 40, 60 and 120 minutesChange in the endothelial glycocalyx thickness by PBR method

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026