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Effect of Fluid Challenge on Glycocalyx

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ClinicalTrials.gov Identifier: NCT03891342
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
University Hospital Pilsen
Information provided by (Responsible Party):
Vladimir Cerny, University Hospital Hradec Kralove

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anesthesia Endothelial Dysfunction Sepsis Septic Shock Surgery Drug: Fluid bolus administration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with sepsis/septic shock
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
 Drug: Fluid bolus administration
Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.
Other Name: Fluid challenge
Experimental: Major surgical patients
Comaprison of fast or slow fluid bolus administration in patients undergoing major surgery requiring fluid challenge as assessed by clinical examination
 Drug: Fluid bolus administration
Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.
Other Name: Fluid challenge


Outcome Measures
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Primary Outcome Measures :
  1. Influence of balanced crystalloid infusion time on endothelial glycocalyx [ Time Frame: baseline and at 20, 40, 60 and 120 minutes ]
    Change in the endothelial glycocalyx thickness by PBR method


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891342


Locations
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Czechia
FN Plzen
Plzen, Czechia
Sponsors and Collaborators
University Hospital Hradec Kralove
University Hospital Pilsen
Investigators
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Principal Investigator: Jan Benes, Assoc.Prof. Charles University hospital in Plzen, Czech Republic
More Information
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Responsible Party: Vladimir Cerny, Principal Investigator, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier: NCT03891342    
Other Study ID Numbers: AZVCR 9307_1
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Shock