Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00885404




Registration number
NCT00885404
Ethics application status
Date submitted
21/04/2009
Date registered
22/04/2009
Date last updated
25/02/2010

Titles & IDs
Public title
Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation
Scientific title
A Prospective, Before and After Study of the Impact of Lower Chloride Intravenous Fluid Management on Patients' Acid-base Status, Renal Profile,Length of Stay and Mortality.
Secondary ID [1] 0 0
2008/03445
Universal Trial Number (UTN)
Trial acronym
CHLORIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shock 0 0
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lower chloride fluids (Hartmann's solution and Plasmalyte®)

Other: Intravenous fluids -


Treatment: Drugs: Lower chloride fluids (Hartmann's solution and Plasmalyte®)
Intravenous fluids used during the 6 month intervention period (after). Amount of fluids to be used is based on clinicians' discretion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean base excess during hospital stay
Timepoint [1] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [1] 0 0
Unmeasured anions (strong ion gap) and chloride levels during hospital stay
Timepoint [1] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [2] 0 0
Serum creatine levels
Timepoint [2] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [3] 0 0
Length of ICU stay
Timepoint [3] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [4] 0 0
Length of Emergency Department stay
Timepoint [4] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [5] 0 0
Length of hospital stay
Timepoint [5] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [6] 0 0
In-hospital mortality
Timepoint [6] 0 0
Six month control period (before) and 6 month intervention period (after)

Eligibility
Key inclusion criteria
* All Intensive Care Unit (ICU) admissions at Austin Hospital
* All Emergency Department (ED) admissions at Austin Hospital
* All operations at Operating Theatre (OT) with hospital stay of more than 48 hours
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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



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

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2010
Actual
Sample size
Target
7000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nor'azim Mohd Yunos, MBBS
Address 0 0
Department of Intensive Care, Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00885404