ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611001021965

Ethics application status

Approved

Date submitted

22/09/2011

Date registered

23/09/2011

Date last updated

10/07/2019

Date data sharing statement initially provided

10/07/2019

Date results provided

10/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A pilot trial of a hypertonic saline bolus in early sepsis

Scientific title

A pilot randomised trial comparing the inflammatory response to hypertonic saline versus normal saline as the initial fluid bolus in adults presenting to the emergency department with presumed early sepsis

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1124-7095

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sepsis

Condition category

Condition code

Infection

Other infectious diseases

Inflammatory and Immune System

Other inflammatory or immune system disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Single intravenous bolus of 5ml/kg of hypertonic (3%) saline solution

Intervention code [1]

Treatment: Other

Comparator / control treatment

Single intravenous bolus of 10ml/kg of normal (0.9%) saline solution

Control group

Active

Outcomes

Primary outcome [1]

Circulating levels of interleukin-1 (used as an indicative inflammatory cytokine) compared to baseline level before fluid bolus. 3.5 mL serum tubes are collected from the patients at the requisite timepoints, allowed to stand at room temperature for 30 minutes to clot then centrifuged at 800g for 10 minutes at 4 deg C. Serum and plasma samples are aliquotted, stored immediately at -80 deg C and subsequently analysed using ELISA.

Timepoint [1]

1, 3 and 24 hours after fluid bolus

Secondary outcome [1]

Inflammatory gene activation and expression measured using qPCR compared to baseline level before fluid bolus. At the requisite timepoints 2.5mL PAXGene tubes are collected. The PAXgene tube is placed immediately at 4 deg C before being transferred to -20 deg C with 72 hours, and then transferred to -80 deg C for long-term storage and subsequent qPCR analysis.

Timepoint [1]

1, 3 and 24 hours after fluid bolus

Secondary outcome [2]

Bacterial load compared to baseline level before fluid bolus. Bacterial load is measured from PAXGene tubes as above.

Timepoint [2]

1, 3 and 24 hours after fluid bolus

Secondary outcome [3]

Haemodynamic parameters (e.g. mean arterial pressure, systolic pressure, heart rate measured non-invasively using standard equipment) compared to baseline level before fluid bolus

Timepoint [3]

1, 3 and 24 hours after fluid bolus

Secondary outcome [4]

Mortality measured by review of medical records and, where necessary, telephone follow up

Timepoint [4]

28 days from enrolment

Eligibility

Key inclusion criteria

1. Suspected or proven infection
2. Two or more SIRS criteria (HR>90/min, RR>20/min, T>38 deg C, WCC>12 (or temp<36 deg C and WCC<4))
3. Fluid bolus indicated clinically
4. Informed consent

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Contraindication to volume loading (e.g. coexistent acute pulmonary oedema)
2. Severe hypotension (SBP<90) requiring immediate resuscitation
3. Plasma sodium concentration outside normal range (135-145 mEq/L)
4. Established significant metabolic acidosis (venous pH <7.25)
5. Established significant renal failure eGFR < 45 mL/min/1.73m2
6. Pregnancy
7. Age less than 16 years of age
8. Deemed for palliative/supportive care only
9. Received prehospital IV fluids >500 mL in total

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)

Eligible patients will be identified by clinical staff working in the emergency department and , once informed consent is obtained, allocation will occur by logging on to a secure website that will randomise the patient to their treatment group. The staff identifying inclusion criteria is therefore unaware to which arm the patient will be randomised until after they consent the patient and log on to the website.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Patients will be randomised in real time utilising a web based randomisation system

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/11/2011

Actual

19/11/2011

Date of last participant enrolment

Anticipated

Actual

5/04/2015

Date of last data collection

Anticipated

Actual

5/05/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Perth Hospital

Address [1]

GPO Box X2213
Perth WA
6847

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Perth Hospital

Address

GPO Box X2213
Perth WA
6847

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Perth Hospital HREC

Ethics committee address [1]

GPO Box X2213
Perth WA
6847

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/07/2011

Approval date [1]

12/09/2011

Ethics approval number [1]

EC 2011-091

Summary

Brief summary

Patients with sepsis have the potential to become very unwell in a rapid period. The progression from being moderately unwell to severely unwell may be due to the body’s immune system responding to the infection, rather than the infection itself.
A fundamental and accepted practice in the management of patients with suspected sepsis is the administration of intravenous fluids. There is no consensus that any particular fluid is better than the other. In particular, we do not know whether any time of fluid has a beneficial effect on this immune response to infection.
Hypertonic saline fluid has been shown in some animal and human studies to influence the immune response to infection. In this pilot study we will assess whether hypertonic saline has an advantage over normal saline in producing beneficial immunomodulation. If this can be shown, it will inform the design of a larger multicentre trial with clinical endpoints.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Glenn Arendts

Address

CCREM Emergency Department, Royal Perth Hospital GPO Box X2213 Perth WA 6847

Country

Australia

Phone

61 8 92248458

Fax

glenn.arendts@uwa.edu.au

Contact person for public queries

Name

Sophie Damianopoulos

Address

CCREM
Emergency Department, Royal Perth Hospital
GPO Box X2213
Perth WA 6847

Country

Australia

Phone

61 8 92248458

Fax

sophie.damianopoulos@health.wa.gov.au

Contact person for scientific queries

Name

Glenn Arendts

Address

CCREM
Emergency Department, Royal Perth Hospital
GPO Box X2213
Perth WA 6847

Country

Australia

Phone

61 8 92248458

Fax

glenn.arendts@uwa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Trial was envisaged, designed and approved before these requirements became commonplace.The PICF for this trial clearly states that only the investigators will have access to participant data, and it is unethical to now share these data

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

Source	Title	Year of Publication	DOI
Embase	Bolus therapy with 3% hypertonic saline or 0.9% saline in emergency department patients with suspected sepsis: A pilot randomised controlled trial.	2019	https://dx.doi.org/10.1016/j.jcrc.2019.03.009

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically