NCT00885404

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 25, 2010

Status Verified

February 1, 2010

Enrollment Period

6 months

First QC Date

April 21, 2009

Last Update Submit

February 24, 2010

Conditions

ShockCritical Illness

Keywords

chlorideacidosis

Outcome Measures

Primary Outcomes (1)

  • Mean base excess during hospital stay

    Six month control period (before) and 6 month intervention period (after)

Secondary Outcomes (6)

  • Unmeasured anions (strong ion gap) and chloride levels during hospital stay

    Six month control period (before) and 6 month intervention period (after)

  • Serum creatine levels

    Six month control period (before) and 6 month intervention period (after)

  • Length of ICU stay

    Six month control period (before) and 6 month intervention period (after)

  • Length of Emergency Department stay

    Six month control period (before) and 6 month intervention period (after)

  • Length of hospital stay

    Six month control period (before) and 6 month intervention period (after)

  • +1 more secondary outcomes

Study Arms (1)

Intravenous fluids

OTHER
Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®)

Interventions

Lower chloride fluids (Hartmann's solution and Plasmalyte®)DRUG

Intravenous fluids used during the 6 month intervention period (after). Amount of fluids to be used is based on clinicians' discretion.

Also known as: Plasmalyte, Lactated solution
Intravenous fluids

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

Location

Related Publications (15)

  • Stewart PA. How to understand acid-base. A Quantitative Primer for Biology and Medicine. New York: Elsevier, 1981.

    BACKGROUND

  • Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. doi: 10.1139/y83-207.

    PMID: 6423247BACKGROUND

  • Sirker AA, Rhodes A, Grounds RM, Bennett ED. Acid-base physiology: the 'traditional' and the 'modern' approaches. Anaesthesia. 2002 Apr;57(4):348-56. doi: 10.1046/j.0003-2409.2001.02447.x.

    PMID: 11939993BACKGROUND

  • Constable PD. Hyperchloremic acidosis: the classic example of strong ion acidosis. Anesth Analg. 2003 Apr;96(4):919-922. doi: 10.1213/01.ANE.0000053256.77500.9D. No abstract available.

    PMID: 12651634BACKGROUND

  • 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. doi: 10.1097/00000542-199710000-00052. No abstract available.

    PMID: 9357917BACKGROUND

  • Story DA, Liskaser F, Bellomo R. Saline infusion, acidosis, and the Stewart approach. Anesthesiology. 2000 Feb;92(2):624; author reply 626. doi: 10.1097/00000542-200002000-00053. No abstract available.

    PMID: 10691256BACKGROUND

  • 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. doi: 10.1046/j.1365-2044.2001.01983.x.

    PMID: 11412158BACKGROUND

  • 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.

    PMID: 12519083BACKGROUND

  • Dorje P, Adhikary G, Tempe DK. Avoiding latrogenic hyperchloremic acidosis--call for a new crystalloid fluid. Anesthesiology. 2000 Feb;92(2):625-6. doi: 10.1097/00000542-200002000-00055. No abstract available.

    PMID: 10691258BACKGROUND

  • 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. doi: 10.1097/00003246-200201000-00022.

    PMID: 11902256BACKGROUND

  • 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. doi: 10.1097/00003246-200202000-00006.

    PMID: 11889298BACKGROUND

  • 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. doi: 10.1007/s00134-004-2176-x. Epub 2004 Feb 28.

    PMID: 14991093BACKGROUND

  • 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. doi: 10.1213/01.ane.0000221449.67354.52.

    PMID: 16790643BACKGROUND

  • Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.

    PMID: 23073953DERIVED

  • Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.

    PMID: 21705897DERIVED

MeSH Terms

Conditions

ShockCritical IllnessAcidosis

Interventions

Ringer's LactatePlasmalyte A

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Nor'azim Mohd Yunos, MBBS

    Department of Intensive Care, Austin Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

February 25, 2010

Record last verified: 2010-02

Locations

AU(1)