NCT03891342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

2.4 years

First QC Date

October 24, 2017

Last Update Submit

March 25, 2019

Conditions

AnesthesiaEndothelial DysfunctionSepsisSeptic ShockSurgery

Outcome Measures

Primary Outcomes (1)

  • Influence of balanced crystalloid infusion time on endothelial glycocalyx

    Change in the endothelial glycocalyx thickness by PBR method

    baseline and at 20, 40, 60 and 120 minutes

Study Arms (2)

Patients with sepsis/septic shock

EXPERIMENTAL

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

Major surgical patients

EXPERIMENTAL

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

Interventions

Fluid bolus administrationDRUG

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

Also known as: Fluid challenge
Major surgical patientsPatients with sepsis/septic shock

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • arm A: age over 18, diagnosis sepsis, fluid bolus administration indicated, arm B: age 18-70, ASA status I-III, major surgery

You may not qualify if:

  • none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FN Plzen

Pilsen, Czechia

Location

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Jan Benes, Assoc.Prof.

    Charles University hospital in Plzen, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2017

First Posted

March 27, 2019

Study Start

February 1, 2016

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

CZ(1)