Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000453987
Ethics application status
Approved
Date submitted
28/04/2011
Date registered
3/05/2011
Date last updated
5/11/2018
Date data sharing statement initially provided
5/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Crystalloid versus Albumin in the Resuscitation of Emergency Department Patients with Septic Shock
Scientific title
Crystalloid versus Albumin for improving organ dysfunction and microcirculation in Emergency Department Patients with Septic Shock
Secondary ID [1] 260071 0
There are no secondary IDs
Universal Trial Number (UTN)
Trial acronym
CARESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Septic Shock 265746 0
Condition category
Condition code
Infection 265890 265890 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Albumin for fluid resuscitation. Albumin will be given via intravenous injection. Dose will be determined by treating clinician in accordance with current best practice. Albumin will be given during the resuscitation phase while in the Emergency Department
Intervention code [1] 264492 0
Treatment: Other
Comparator / control treatment
Crystalloid for fluid resuscitation
Control group
Active

Outcomes
Primary outcome [1] 266650 0
Organ Dysfunction will be measured using the sequential organ dysfunction assessment tool. This tool requires clinical and laboratory based data that is obtained routinely as part of standard care.
Timepoint [1] 266650 0
0, 6, 24 and 72 hours after trial enrolment
Secondary outcome [1] 276144 0
Sublingual microcirculation will be assessed using the microvision microscan sublingual microcirculation video microscope. Four measures of microcirculation will be calculated using this equipment; capillary density, microvascular flow index, percent of perfused capillaries and perfused capillary density.
Timepoint [1] 276144 0
0, 6, 24 and 72 hours after trial enrolment

Eligibility
Key inclusion criteria
1. Infection (according to treating emergency physician’s clinical assessment)
2. Shock, as defined by either:
a. Hypotension (Systolic blood pressure <90 or Mean arterial pressure <65 despite 20ml/kg fluid bolus), or
b. Elevated lactate (arterial or venous, >4.0 mmol/l)
3. At least 2 systemic inflammatory response syndrome (SIRS) criteria present, defined as
a. Core temperature < 36.0 degrees C or > 38 degrees C
b. Heart rate > 90 beats/minute
c. Respiratory rate > 20 breaths/minute or PaC02 < 32 mmHg
d. White cell count > 12 or < 4 * 109/L

4. Antimicrobials commenced
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inter-hospital transfer
2. >8 hours in ED
3. Death is expected and imminent.
4. Underlying disease process with a life expectancy of <90 days.
5. Jehovah’s Witness
6. Age<18
7. A “limitation of therapy” order has been documented restricting implementation of the study protocol or treating team clinician deems aggressive care unsuitable.

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)
Patients eligible for inclusion will be consented and enrolled while in the Emergency Department. This is an unblinded study. Random allocation concealment will be implemented through the use of serially numbered, tamper-evident envelopes. The envelopes contain group assignment, study instructions and data sheets
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation sequence will generated with the aid of random allocation software . Permuted block randomisation with variable block sizes will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 264961 0
Self funded/Unfunded
Name [1] 264961 0
Country [1] 264961 0
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Butterfield Street, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 264058 0
None
Name [1] 264058 0
Address [1] 264058 0
Country [1] 264058 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266926 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 266926 0
Butterfield Street, Herston, QLD, 4029
Ethics committee country [1] 266926 0
Australia
Date submitted for ethics approval [1] 266926 0
Approval date [1] 266926 0
29/03/2011
Ethics approval number [1] 266926 0
HREC/11/QRBW/33

Summary
Brief summary
Individuals who present to the Emergency Department with severe infections are treated with fluids in the vein to maintain optimal blood volume, keep the heart working properly, and keep tissues well oxygenated. There are a number of fluids that Emergency Physicians can provide to patients including saline and 4% albumin. Further work is required to determine which of these fluids is most effective in improving the outcome of patients with severe infection.

This project aims to determine whether 4% albumin solution is superior to crystalloid solutions for fluid resuscitation of patients presenting to the Emergency Department (ED) with septic shock. A randomised controlled trial is proposed, in which 100 patients will be enrolled over 2 years, each assigned to receive either 4% albumin or crystalloid fluids for the first six hours of resuscitation in the ED. All other aspects of care will be common to both groups and according to evidence-based guidelines. A variety of outcomes will be measured, including organ dysfunction scores, inflammatory markers and measures of circulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32543 0
Dr Julian Williams
Address 32543 0
Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, 4029
Country 32543 0
Australia
Phone 32543 0
+61 36468111
Fax 32543 0
Email 32543 0
julian.williams@health.qld.gov.au
Contact person for public queries
Name 15790 0
Dr Dr Julian Williams
Address 15790 0
Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD 4029
Country 15790 0
Australia
Phone 15790 0
+61 7 3636 7901
Fax 15790 0
61 7 3636 1643
Email 15790 0
julian_williams@health.qld.gov.au
Contact person for scientific queries
Name 6718 0
Dr Dr Julian Williams
Address 6718 0
Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD 4029
Country 6718 0
Australia
Phone 6718 0
+61 7 3636 7901
Fax 6718 0
+61 7 3636 1643
Email 6718 0
julian_williams@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This trial was ended before data collection commenced


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.