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Effect of Fluid Challenge on Glycocalyx

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 24, 2017
First Posted Date  ICMJE March 27, 2019
Last Update Posted Date March 27, 2019
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fluid Challenge on Glycocalyx
Official Title  ICMJE Comparing of Two Regimes (Fast and Slow) of Fluid Challenge on Glycocalyx Assessed by Perfused Boundary Region in Septic and Elective Major Surgical Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Anesthesia
  • Endothelial Dysfunction
  • Sepsis
  • Septic Shock
  • Surgery
Intervention  ICMJE Drug: Fluid bolus administration
Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.
Other Name: Fluid challenge
Study Arms  ICMJE
  • 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
    Intervention: Drug: Fluid bolus administration
  • 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
    Intervention: Drug: Fluid bolus administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2019)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03891342
Other Study ID Numbers  ICMJE AZVCR 9307_1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Vladimir Cerny, University Hospital Hradec Kralove
Study Sponsor  ICMJE University Hospital Hradec Kralove
Collaborators  ICMJE University Hospital Pilsen
Investigators  ICMJE
Principal Investigator: Jan Benes, Assoc.Prof. Charles University hospital in Plzen, Czech Republic
PRS Account University Hospital Hradec Kralove
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP