Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation

NCT ID: NCT00885404

Last Updated: 2010-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

7000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-08-31

Brief Summary

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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®).

Detailed Description

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This is a prospective, controlled, before-and-after study. The baseline pre-intervention period will include collection of data while doctors and nurses are unaware that such collection is taking place. During this time, high chloride fluids (saline, Gelofusine, 4% albumin) will continue to be used according to standard practice with an estimated 30,000 liters of saline as well as 2,000 bottles of Gelofusine® being consumed.

Following a wash out period of education and preparation, there will be a complete shift to a working environment where use of saline, Gelofusine and any other fluids with a high chloride level (\>110 mmol/L)will be restricted and substituted with fluids of lower chloride concentration similar to blood; either Hartmann's solution or Plasmalyte® or 20% albumin.

The study will compare a 6 month control period (before) and a six month intervention period (after).

Conditions

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Shock Critical Illness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous fluids

Group Type OTHER

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

Intervention Type DRUG

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

Interventions

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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 Type DRUG

Other Intervention Names

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Plasmalyte Lactated solution

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austin Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Clinical Research Fellow, Department of Intensive Care, Austin Hospital.

Principal Investigators

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Nor'azim Mohd Yunos, MBBS

Role: PRINCIPAL_INVESTIGATOR

Department of Intensive Care, Austin Health

Locations

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Austin Health

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND
PMID: 6423247 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11939993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12651634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9357917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10691256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11412158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12519083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10691258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11902256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11889298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14991093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16790643 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23073953 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21705897 (View on PubMed)

Other Identifiers

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2008/03445

Identifier Type: -

Identifier Source: org_study_id

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