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Trial registered on ANZCTR


Registration number
ACTRN12618000385246
Ethics application status
Approved
Date submitted
24/11/2017
Date registered
14/03/2018
Date last updated
14/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of the fluid challenge administration rate on the blood circulation variables in anesthetized and critically ill patients
Scientific title
Hemodynamic effects of the fluid challenge administration rate in anesthetized and critically ill patients
Secondary ID [1] 293435 0
None
Universal Trial Number (UTN)
U1111-1205-6526
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fluid challenge 305603 0
anesthesia 305604 0
critically ill 305605 0
Condition category
Condition code
Anaesthesiology 304825 304825 0 0
Other anaesthesiology
Cardiovascular 304826 304826 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous administration of Hartmann´s solution in dose of 5 ml per kg of patient´s body weight to test patient´s hemodynamic response in different rate (fluid challenge) - either fast (5-10minutes - Arm 1/Intervention) or slow (25-30 minutes - Arm 2/Control). The fluid challenge will be performed by the treating physician (anesthesiologist or intensive care physician) during anesthesia (within 30 minutes after induction) or at the intensive care unit (within 48 hours of sepsis onset/ ICU admission).
Intervention code [1] 299677 0
Treatment: Drugs
Intervention code [2] 300266 0
Early detection / Screening
Comparator / control treatment
The slow administration of of 5ml/kg patient´s body weight (fluid challenge) of Hartmann´s solution at rate 25-30 minutes (Arm 2/Control) serves as active dose comparison control. The way of administration is the same as in the Intervention Arm 1 - the fluid challenge will be performed by the treating physician (anesthesiologist or intensive care physician) during anesthesia (within 30 minutes after induction) or at the intensive care unit (within 48 hours of sepsis onset/ ICU admission).
Control group
Active

Outcomes
Primary outcome [1] 304035 0
To assess the difference in rate of fluid challenges deemed "positive" after fast (5-10 minutes) and slow (25-30 minutes) fluid challenge. The fluid challenge may be deemed "positive" based on the hemodynamic response (at least one condition met): either increase in mean arterial pressure more than 20% (after vs. before fluid challenge) or drop in plethysmography variability index of more than 5% (before vs. after fluid challenge) or increase in stroke volume more than 15% (before vs. after fluid challenge).
Timepoint [1] 304035 0
Immediately before (within 5 minutes), immediately after (within 5 minutes) and 60 minutes after the administration.
Secondary outcome [1] 340775 0
To assess the difference in microcirculatory response (perfused boundary region) after fast (5-10 minutes) and slow (25-30 minutes) fluid challenge assessed using intravital microscopy in the sublingual region and dedicated analytical software GlycoCheck.
Timepoint [1] 340775 0
Before (within 5 minutes), immediately after (within 5 minutes) and 60 minutes after the administration.
Secondary outcome [2] 342947 0
To assess the difference in microcirculatory response (capillary density) after fast (5-10 minutes) and slow (25-30 minutes) fluid challenge assessed using intravital microscopy in the sublingual region and dedicated analytical software GlycoCheck.
Timepoint [2] 342947 0
Before (within 5 minutes), immediately after (within 5 minutes) and 60 minutes after the administration.

Eligibility
Key inclusion criteria
all patients undergoing scheduled lumbar spine surgery in general anesthesia or patients with sepsis/septic shock admitted to the intensive care unit within first 48 hours after diagnosis
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with pathology in the oral cavity (bleeding, neoplasia), previously diagnosed systemic microangiopathy and atrial fibrillation were excluded from the trial

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9392 0
Czech Republic
State/province [1] 9392 0

Funding & Sponsors
Funding source category [1] 298064 0
Government body
Name [1] 298064 0
AGENTURA PRO ZDRAVOTNICKÝ VÝZKUM CESKÉ REPUBLIKY
Address [1] 298064 0
Ruská 2412/85,
100 05 Praha 10
Country [1] 298064 0
Czech Republic
Primary sponsor type
Hospital
Name
Charles University Hospital Plzen
Address
alej Svobody 80
306 40, Plzen
Country
Czech Republic
Secondary sponsor category [1] 297140 0
None
Name [1] 297140 0
Address [1] 297140 0
Country [1] 297140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299081 0
Ethical committee of the Charles University hospital and Faculty of Medicine in Plzen
Ethics committee address [1] 299081 0
trida dr.E.Benese 13
305 99, Plzen
Ethics committee country [1] 299081 0
Czech Republic
Date submitted for ethics approval [1] 299081 0
Approval date [1] 299081 0
12/08/2014
Ethics approval number [1] 299081 0

Summary
Brief summary
The aim of this study is to assess the influence of faster and slower fluid challenge administration rate on macrohemodynamic variables and microcircirculation in the population of surgical and septic patients. Our hypothesis was that faster fluid challenge leads to bigger macrohemodynamic effects but harms microcirculation more than slower one.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79234 0
A/Prof Jan Benes
Address 79234 0
Dpt. of Anesthesiology and Intensive care medicine
Charles University hospital
alej Svobody 80
306 40, Plzen
Country 79234 0
Czech Republic
Phone 79234 0
+420377104381
Fax 79234 0
Email 79234 0
benesj@fnplzen.cz
Contact person for public queries
Name 79235 0
A/Prof Jan Benes
Address 79235 0
Dpt. of Anesthesiology and Intensive care medicine
Charles University hospital
alej Svobody 80
306 40, Plzen
Country 79235 0
Czech Republic
Phone 79235 0
+420377104381
Fax 79235 0
Email 79235 0
benesj@fnplzen.cz
Contact person for scientific queries
Name 79236 0
A/Prof Jan Benes
Address 79236 0
Dpt. of Anesthesiology and Intensive care medicine
Charles University hospital
alej Svobody 80
306 40, Plzen
Country 79236 0
Czech Republic
Phone 79236 0
+420377104381
Fax 79236 0
Email 79236 0
benesj@fnplzen.cz

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary