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Trial registered on ANZCTR


Registration number
ACTRN12618001749291p
Ethics application status
Not yet submitted
Date submitted
18/10/2018
Date registered
24/10/2018
Date last updated
24/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of rapid versus slow fluid therapy in ICU patients with severe infection
Scientific title
The hemodynamic and physiological effects of rapid versus slow fluid bolus therapy with 4% albumin in ICU patients with severe sepsis or septic shock
Secondary ID [1] 296368 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 310106 0
Condition category
Condition code
Infection 308851 308851 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is intravenous infusion of 4% Albumin. There will be two arms in this trial, where the participants will be randomised to either:
1. Rapid Fluid Therapy Group (active control group)
10mL/kg of 4% Albumin is given at 100mL/min.

2. Slow Fluid Therapy Group (experimental group)
10mL/kg of 4% Albumin is given at 10mL/min.

The expected duration of the therapy is anywhere from 5 minutes to 120minutes. Above interventions will be performed and monitored closely by experienced ICU research nurse, who will use infusion pump or manual method to run the fluids intravenously at the bedside. The nurses will also ensure the fidelity of the interventions throughout the duration of therapy. The intervention will not involve any more invasive procedures to the patient who is already admitted in ICU.
Intervention code [1] 312702 0
Treatment: Other
Comparator / control treatment
Comparator is the group receiving a rapid fluid therapy (i.e., 10mL/kg of 4% Albumin given at 100mL/min), as we are testing the hypothesis that slow fluid therapy with 4% albumin will lead to a greater increase in stroke work as well as more prolonged favourable changes in hemodynamic parameters compared to rapid bolus.
Control group
Active

Outcomes
Primary outcome [1] 307826 0
Stroke Work measured by Echocardiography machine (non-invasive ultrasound machine).
Timepoint [1] 307826 0
Measured at every 30 minutes after the completion of fluid therapy (given either rapidly or slowly) for 2 hours duration (i.e., 30min, 60min, 90min, and 120min after the completion of fluid infusion). Primary endpoint will be the calculated mean value of all the measured data.
Secondary outcome [1] 353070 0
Stroke Volume measaured using Echocardiography machine.
Timepoint [1] 353070 0
Stroke volume is measured every 30 min after the completion of fluid infusion for 2 hours (30, 60, 90, and 120 min post infusion),
Secondary outcome [2] 353112 0
Blood pressure, both systolic and mean arterial pressure will be measured via arterial line monitoring device
Timepoint [2] 353112 0
Blood pressure is measured every 30 min after the completion of fluid infusion for 2 hours (30, 60, 90, and 120 min post infusion),
Secondary outcome [3] 353113 0
Heart Rate measured by 3 lead ECG
Timepoint [3] 353113 0
Heart Rate is measured every 30 min after the completion of fluid infusion for 2 hours (30, 60, 90, and 120 min post infusion).


Secondary outcome [4] 353121 0
Lactate measured by taking arterial blood gas sample and running the serum assay
Timepoint [4] 353121 0
Lactate is measured at 15min, 30min, 45min, 60min, 90min, and 120min after the completion of fluid infusion.
Secondary outcome [5] 353122 0
Urine output measured by the bedside nurse by checking urine drainge bag
Timepoint [5] 353122 0
Urine output is measured at every 15 minutes after the completion of the fluid therapy.

Eligibility
Key inclusion criteria
• Admitted to ICU
• Age 18 years or older
• Meeting clinical criteria for fluid bolus administration (one of the following):
o MAP <65mmHg
o HR >100bpm
o Urine output <0.5ml/kg/hr
o Lactate levels of >3mmol/dL
o Cardiac index <2.5L/min/m2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Evidence of fluid overload or acute pulmonary edema
• Patient has contraindications to receiving albumin (e.g., allergic reaction or Jenovah’s Witness)
• Active bleeding requiring transfusion
• Haemoglobin level <70g/L
• Patients in whom death is considered imminent (within 24 hours)
• Receiving continuous renal replacement therapy (CRRT) or hemodialysis
• Pregnancy
• Expected discharge from ICU during 2 hour monitoring period
• Inability to give consent or refusing to consent
• Inability to obtain satisfactory echocardiographic images for cardiac output measurement

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The calculated target sample size is 68. The rationale is based on the previous fluid study, where we anticipate the increase in MAP with rapid infusion was 71 (65- 78) to 73 (68-80) (median and IQR), and in slow infusion group, we anticipate 35% further increase in MAP with similar data distribution, then with the power of 80% and alpha of 0.2, we will require total of 68 patients in the study (34 in each arm), even if we consider 10% attrition.

The above endpoints will be measured and plotted on a graph over time to follow the trend and their mean values being compared.

Citation :
Bihari, Prakash, and Bersten. Post Resuscitation Fluid Boluses In Severe Sepsis Or Septic Shock: Prevalence And Efficacy (PRICE Study). SHOCK 2013. Vol. 40, No. 1, pp. 28Y34,

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
Date of last participant enrolment
Anticipated
2/03/2020
Actual
Date of last data collection
Anticipated
1/03/2021
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 24383 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300973 0
Other
Name [1] 300973 0
College of Intensive Care Medicine
Country [1] 300973 0
Australia
Primary sponsor type
Individual
Name
Taeseon Shin
Address
Flinders Medical Centre. Flinders Drive. Bedford Park SA 5042 Australia
Country
Australia
Secondary sponsor category [1] 300553 0
None
Name [1] 300553 0
Address [1] 300553 0
Country [1] 300553 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301735 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 301735 0
Research Ethics Office

Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 301735 0
Australia
Date submitted for ethics approval [1] 301735 0
24/10/2018
Approval date [1] 301735 0
Ethics approval number [1] 301735 0

Summary
Brief summary
This research aims to compare the effect of rapid versus slow fluid therapy in ICU patients with severe infection. In this study, we plan to randomly allocate 68 critically ill ICU patients to receive either rapid or slow fluid infusion therapy and measure parameters associated with blood circulation. We hypothesize that slow fluid therapy will lead to a greater increase in overall output from the heart, blood pressure, as well as other indicators of blood volume expansion,compared to those after rapid infusion.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3176 3176 0 0
/AnzctrAttachments/376219-Participant Consent form.doc (Participant information/consent)
Attachments [2] 3177 3177 0 0
/AnzctrAttachments/376219-Project Description.docx (Other)

Contacts
Principal investigator
Name 87934 0
Dr Taeseon Shin
Address 87934 0
Intensive and Critical Care Unit, Flinders Medical Centre, Flinders Drive, Bedford Park 5042 SA
Country 87934 0
Australia
Phone 87934 0
+61409824140
Fax 87934 0
Email 87934 0
[email protected]
Contact person for public queries
Name 87935 0
Taeseon Shin
Address 87935 0
Intensive and Critical Care Unit, Flinders Medical Centre, Flinders Drive, Bedford Park 5042 SA
Country 87935 0
Australia
Phone 87935 0
+61409824140
Fax 87935 0
Email 87935 0
[email protected]
Contact person for scientific queries
Name 87936 0
Taeseon Shin
Address 87936 0
Intensive and Critical Care Unit, Flinders Medical Centre, Flinders Drive, Bedford Park 5042 SA
Country 87936 0
Australia
Phone 87936 0
+61409824140
Fax 87936 0
Email 87936 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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