Effect of Fluid Challenge on Glycocalyx

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

Tracking Information

• First Submitted Date: October 24, 2017
• First Posted Date: March 27, 2019
• Last Update Posted Date: March 27, 2019
• Actual Study Start Date: February 2016
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Fluid Challenge on Glycocalyx
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment

Condition

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

Intervention

Drug: Fluid bolus administration

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

Other Name: Fluid challenge

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 25, 2019): 120
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2018
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czechia

Administrative Information

• NCT Number: NCT03891342
• Other Study ID Numbers: AZVCR 9307_1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Vladimir Cerny, University Hospital Hradec Kralove
• Study Sponsor: University Hospital Hradec Kralove
• Collaborators: University Hospital Pilsen

Investigators

• Principal Investigator: Jan Benes, Assoc.Prof.; Charles University hospital in Plzen, Czech Republic

• PRS Account: University Hospital Hradec Kralove
• Verification Date: March 2019