Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2016-02-29
2018-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Fluid bolus administration
Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.
Major surgical patients
Comaprison of fast or slow fluid bolus administration in patients undergoing major surgery requiring fluid challenge as assessed by clinical examination
Fluid bolus administration
Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.
Interventions
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Fluid bolus administration
Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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University Hospital Pilsen
OTHER
University Hospital Hradec Kralove
OTHER
Responsible Party
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Vladimir Cerny
Principal Investigator
Principal Investigators
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Jan Benes, Assoc.Prof.
Role: PRINCIPAL_INVESTIGATOR
Charles University hospital in Plzen, Czech Republic
Locations
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FN Plzen
Pilsen, , Czechia
Countries
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Other Identifiers
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AZVCR 9307_1
Identifier Type: -
Identifier Source: org_study_id
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