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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00885404
Ethics application status
Date submitted
21/04/2009
Date registered
21/04/2009
Date last updated
24/02/2010

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
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®)
Treatment: Drugs - Lower chloride fluids (Hartmann's solution and Plasmalyte®)

Other: Intravenous fluids -

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.

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)
Primary outcome [2] 0 0
Mean base excess during hospital stay
Timepoint [2] 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)
Secondary outcome [7] 0 0
Unmeasured anions (strong ion gap) and chloride levels during hospital stay
Timepoint [7] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [8] 0 0
Serum creatine levels
Timepoint [8] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [9] 0 0
Length of ICU stay
Timepoint [9] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [10] 0 0
Length of Emergency Department stay
Timepoint [10] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [11] 0 0
Length of hospital stay
Timepoint [11] 0 0
Six month control period (before) and 6 month intervention period (after)
Secondary outcome [12] 0 0
In-hospital mortality
Timepoint [12] 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
Gender
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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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 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
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether intravenous fluid management using lower
chloride solutions (Hartmann's solutions and Plasmalyte®) will result in better outcome when
compared to management using high chloride solutions (0.9% saline and Gelofusine®).
Trial website
https://clinicaltrials.gov/show/NCT00885404
Trial related presentations / publications
Stewart PA. How to understand acid-base. A Quantitative Primer for Biology and Medicine. New York: Elsevier, 1981.
Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61.
Sirker AA, Rhodes A, Grounds RM, Bennett ED. Acid-base physiology: the 'traditional' and the 'modern' approaches. Anaesthesia. 2002 Apr;57(4):348-56. Review.
Constable PD. Hyperchloremic acidosis: the classic example of strong ion acidosis. Anesth Analg. 2003 Apr;96(4):919-22. Review.
Dorje P, Adhikary G, McLaren ID, Bogush S. Dilutional acidosis or altered strong ion difference. Anesthesiology. 1997 Oct;87(4):1011-2; author reply 1013-4.
Story DA, Liskaser F, Bellomo R. Saline infusion, acidosis, and the Stewart approach. Anesthesiology. 2000 Feb;92(2):624; author reply 626.
Story DA, Poustie S, Bellomo R. Quantitative physical chemistry analysis of acid-base disorders in critically ill patients. Anaesthesia. 2001 Jun;56(6):530-3.
Reid F, Lobo DN, Williams RN, Rowlands BJ, Allison SP. (Ab)normal saline and physiological Hartmann's solution: a randomized double-blind crossover study. Clin Sci (Lond). 2003 Jan;104(1):17-24.
Dorje P, Adhikary G, Tempe DK. Avoiding latrogenic hyperchloremic acidosis--call for a new crystalloid fluid. Anesthesiology. 2000 Feb;92(2):625-6.
Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during in vitro hemodilution. Crit Care Med. 2002 Jan;30(1):157-60.
Kellum JA. Fluid resuscitation and hyperchloremic acidosis in experimental sepsis: improved short-term survival and acid-base balance with Hextend compared with saline. Crit Care Med. 2002 Feb;30(2):300-5.
Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during acute normovolaemic haemodilution. Intensive Care Med. 2004 Jul;30(7):1432-7. Epub 2004 Feb 28.
Story DA, Morimatsu H, Bellomo R. Hyperchloremic acidosis in the critically ill: one of the strong-ion acidoses? Anesth Analg. 2006 Jul;103(1):144-8, table of contents.
Stewart PA. How to understand acid-base. A Quantitative Primer for Biology and Medicine. New York: Elsevier, 1981.
Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61.
Sirker AA, Rhodes A, Grounds RM, Bennett ED. Acid-base physiology: the 'traditional' and the 'modern' approaches. Anaesthesia. 2002 Apr;57(4):348-56. Review.
Constable PD. Hyperchloremic acidosis: the classic example of strong ion acidosis. Anesth Analg. 2003 Apr;96(4):919-22. Review.
Dorje P, Adhikary G, McLaren ID, Bogush S. Dilutional acidosis or altered strong ion difference. Anesthesiology. 1997 Oct;87(4):1011-2; author reply 1013-4.
Story DA, Liskaser F, Bellomo R. Saline infusion, acidosis, and the Stewart approach. Anesthesiology. 2000 Feb;92(2):624; author reply 626.
Story DA, Poustie S, Bellomo R. Quantitative physical chemistry analysis of acid-base disorders in critically ill patients. Anaesthesia. 2001 Jun;56(6):530-3.
Reid F, Lobo DN, Williams RN, Rowlands BJ, Allison SP. (Ab)normal saline and physiological Hartmann's solution: a randomized double-blind crossover study. Clin Sci (Lond). 2003 Jan;104(1):17-24.
Dorje P, Adhikary G, Tempe DK. Avoiding latrogenic hyperchloremic acidosis--call for a new crystalloid fluid. Anesthesiology. 2000 Feb;92(2):625-6.
Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during in vitro hemodilution. Crit Care Med. 2002 Jan;30(1):157-60.
Kellum JA. Fluid resuscitation and hyperchloremic acidosis in experimental sepsis: improved short-term survival and acid-base balance with Hextend compared with saline. Crit Care Med. 2002 Feb;30(2):300-5.
Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during acute normovolaemic haemodilution. Intensive Care Med. 2004 Jul;30(7):1432-7. Epub 2004 Feb 28.
Story DA, Morimatsu H, Bellomo R. Hyperchloremic acidosis in the critically ill: one of the strong-ion acidoses? Anesth Analg. 2006 Jul;103(1):144-8, table of contents.
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00885404