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Trial registered on ANZCTR


Registration number
ACTRN12607000259448
Ethics application status
Approved
Date submitted
11/05/2007
Date registered
15/05/2007
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of hypertonic fluid administration in patients with severe sepsis or septic shock
Scientific title
The effects of hypertonic fluid administration on gastrointestinal
perfusion and sublingual microcirculation, in patients with severe
sepsis or septic shock.
Secondary ID [1] 262235 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe sepsis or septic shock 1798 0
Condition category
Condition code
Blood 1885 1885 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: iv infusion over 15 minutes of 250 mls hyperhaes (7.2% NaCl [Sodium Chloride] / 6% Hydroxy Ethyl Starch).
Intervention code [1] 1751 0
Treatment: Other
Comparator / control treatment
Control: iv infusion over 15 minutes of 500 mls starquin (6% Hydroxy Ethyl Starch).
Control group
Active

Outcomes
Primary outcome [1] 2681 0
Tonometry: Assuming a baseline value of 10 and a standard deviation of 9 mmHg (based on an earlier study), we calculated a sample size of 24 patients to detect an absolute difference between groups in P[g-a]CO2 gap of 12mmHg after the intervention in a two-sided test with an alpha level of 0.05 and power >80%.
Timepoint [1] 2681 0
Measured at baseline and every 30 minutes for 6 hours
Secondary outcome [1] 4535 0
Semiquantitative analysis of sublingual microcirculation
Timepoint [1] 4535 0
Measured at baseline and after 1 hour
Secondary outcome [2] 4536 0
Haemodynamic parameters (blood pressure, cardiac output).
Timepoint [2] 4536 0
Measured at baseline and every 30 minutes for 6 hours.
Secondary outcome [3] 4537 0
Expression of mRNA (TF, IL6, IL8, IL10, CD11b, TGFb, MCP1, MMP9, ICAM1, L-selectin, HILG) measured by realtime polymerase chain reaction (PCR) techniques.
Timepoint [3] 4537 0
Measured at baseline and after 4, 8, 12, and 24 hours.
Secondary outcome [4] 276452 0
Systolic and diastolic function as measured with echocardiography.
Timepoint [4] 276452 0
Measured at baseline and after 1 hour.

Eligibility
Key inclusion criteria
Patients with severe sepsis or septic shock and need for fluid resuscitation (stroke volume variation > 12% or by clinical judgment)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, hyponatremia (serum sodium level < 130 mmol/l), hypernatremia (serum sodium level > 150 mmol/l), arrhythmias, myocardial infarction < 1 month prior to study

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)
Concealed allocation by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (coin tossing)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinded in the study are: assessors, and data analysts
Phase
Type of endpoint(s)
Efficacy
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] 521 0
New Zealand
State/province [1] 521 0
Waikato

Funding & Sponsors
Funding source category [1] 2033 0
Charities/Societies/Foundations
Name [1] 2033 0
Waikato Medical Research Foundation
Address [1] 2033 0
Peter Rothwell Academic Centre
Private Bag 3200
Hamilton
Country [1] 2033 0
New Zealand
Primary sponsor type
Individual
Name
Dr Frank van Haren
Address
Department of Intensive Care
Waikato Hospital
Private Bag 3200
Hamilton
Country
New Zealand
Secondary sponsor category [1] 1841 0
Individual
Name [1] 1841 0
Prof Jamie Sleigh
Address [1] 1841 0
Waikato Hospital
Hamilton
Country [1] 1841 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3765 0
Waikato Hospital
Ethics committee address [1] 3765 0
Ethics committee country [1] 3765 0
Australia
Date submitted for ethics approval [1] 3765 0
Approval date [1] 3765 0
16/10/2006
Ethics approval number [1] 3765 0
NTY/06/08/070

Summary
Brief summary
Patients with severe sepsis (infection) frequently die. Sepsis interferes with the clotting and inflammatory systems and affects the heart, blood pressure as well as tissue oxygenation of the body. Vigorous fluid administration can restore the volume necessary to ensure blood and oxygen are carried around the body but may not be sufficient for good tissue perfusion. Hypertonic fluid which has a higher concentration of salt, is thought to both increase heart function and improve the flow of blood and oxygen into the micro tissues that supply the body. It is also thought to improve immune function. In this study we hope to randomise 24 eligible Intensive Care patients with severe sepsis, into two groups; a control group which will receive 500mls of 6% HES solution and the treatment group which will receive 250mls of Hyperhes hypertonic fluid. A variety of invasive and non-invasive measurements and blood tests will be taken over a six hour period. Demographic data and illness severity scores will be recorded as well as usual haemodynamic measures and recordings for seriously ill patients.
Statistical analysis using standard techniques, will be done on SPSS version 10.0
Hyperhes, evaluated in previous studies, is regarded as a safe and well tolerated treatment for shock.
Trial website
Trial related presentations / publications
Hypertonic Fluid Administration in Patients With Septic Shock: A Prospective Randomized Controlled Pilot Study. Van Haren FM, Sleigh J, Boerma EC, La Pine M, Bahr M, Pickkers P, van der Hoeven JG. Shock. 2012 March; 37(3): 268-275

The effects of hypertonic fluid administration on the gene expression of inflammatory mediators in circulating leucocytes in patients with septic shock: a preliminary study. Van Haren FM, Sleigh J, Cursons R, La Pine M, Pickkers P, van der Hoeven JG. Annals of Intensive Care. 2011 Nov 1;1(1):44
Public notes

Contacts
Principal investigator
Name 27854 0
A/Prof Frank van Haren
Address 27854 0
ICU, Canberra Hospital
PO Box 11
Woden 2606
Australia
Country 27854 0
Australia
Phone 27854 0
+61262442222
Fax 27854 0
Email 27854 0
frank.vanharen@act.gov.au
Contact person for public queries
Name 10940 0
Mrs Mary LaPine, research coordinator
Address 10940 0
Department of Intensive Care
Waikato Hospital
Private Bag 3200
Hamilton
Country 10940 0
New Zealand
Phone 10940 0
+64 78398899
Fax 10940 0
+64 78398912
Email 10940 0
lapinem@waikatodhb.govt.nz
Contact person for scientific queries
Name 1868 0
A/Prof Dr Frank van Haren. MD PhD
Address 1868 0
ICU, Canberra Hospital
PO Box 11
Woden 2606
Australia
Country 1868 0
Australia
Phone 1868 0
+61262442222
Fax 1868 0
+61262443507
Email 1868 0
fvanharen@me.com

No information has been provided regarding IPD availability
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