AnesthesiaNCT03891342
Effect of Fluid Challenge on Glycocalyx
A study testing Fluid bolus administration in people with Anesthesia and Endothelial Dysfunction, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia, Endothelial Dysfunction, Sepsis
- What is being tested?
- Fluid bolus administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- Feb 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arm A: age over 18, diagnosis sepsis, fluid bolus administration indicated, arm B: age 18-70, ASA status I-III, major surgery
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anesthesia, Endothelial Dysfunction, Sepsis, Septic Shock, Surgery
- Being tested
- Fluid bolus administration
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid bolus administrationDrug
Also called Fluid challenge
Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Fluid bolus administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of balanced crystalloid infusion time on endothelial glycocalyx
Change in the endothelial glycocalyx thickness by PBR method
Measured: baseline and at 20, 40, 60 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study startFeb 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Pilsen
- Responsible party
- Principal investigator, Vladimir Cerny, University Hospital Hradec Kralove
- Investigators
- Jan Benes, Assoc.Prof., Principal investigator, Charles University hospital in Plzen, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891342
- Sponsor's protocol ID
- AZVCR 9307_1
- Status last verified
- Mar 2019
- First submitted
- 24 Oct 2017
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03891342
- Acronym / sponsor ID
- AZVCR 9307_1
- Conditions
- Anesthesia, Endothelial Dysfunction, Sepsis, Septic Shock, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Collaborators
- University Hospital Pilsen
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with sepsis/septic shock | Experimental | Drug: Fluid bolus administrationComaprison 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 |
| Major surgical patients | Experimental | Drug: Fluid bolus administrationComaprison of fast or slow fluid bolus administration in patients undergoing major surgery requiring fluid challenge as assessed by clinical examination |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- arm A: age over 18, diagnosis sepsis, fluid bolus administration indicated, arm B: age 18-70, ASA status I-III, major surgery
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid bolus administrationAlso: Fluid challengeFluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes. | Drug | Major surgical patients, Patients with sepsis/septic shock |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Benes, Assoc.Prof. principal investigator
Charles University hospital in Plzen, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid bolus administration in people with Anesthesia and Endothelial Dysfunction, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of balanced crystalloid infusion time on endothelial glycocalyx (time frame: baseline and at 20, 40, 60 and 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.