Clinical trial NCT00885404: Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation
Official 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Shock
Critical Illness
Keywords: chloride
acidosis
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
First posted: 2009-04-22
Enrollment: 7000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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®).

Detailed description: 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).

Eligibility criteria: 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

Exclusion Criteria: Nil

Primary outcomes:
measure: Mean base excess during hospital stay
timeFrame: Six month control period (before) and 6 month intervention period (after)
Secondary outcomes:
measure: Unmeasured anions (strong ion gap) and chloride levels during hospital stay
timeFrame: Six month control period (before) and 6 month intervention period (after)
measure: Serum creatine levels
timeFrame: Six month control period (before) and 6 month intervention period (after)
measure: Length of ICU stay
timeFrame: Six month control period (before) and 6 month intervention period (after)
measure: Length of Emergency Department stay
timeFrame: Six month control period (before) and 6 month intervention period (after)
measure: Length of hospital stay
timeFrame: Six month control period (before) and 6 month intervention period (after)
measure: In-hospital mortality
timeFrame: Six month control period (before) and 6 month intervention period (after)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: Department of Intensive Care, Austin Health
name: Nor'azim Mohd Yunos, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart PA. How to understand acid-base. A Quantitative Primer for Biology and Medicine. New York: Elsevier, 1981.
citation: Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. doi: 10.1139/y83-207.
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.