Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation - Full Text View

Sponsored by:	Austin Health
Information provided by:	Austin Health
ClinicalTrials.gov Identifier:	NCT00885404

Purpose

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®).

Condition	Intervention	Phase
Shock Critical Illness	Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Efficacy Study
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.

Resource links provided by NLM:

Drug Information available for: Chlorides Normosol R

U.S. FDA Resources

Further study details as provided by Austin Health:

Primary Outcome Measures:

Mean base excess during hospital stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Unmeasured anions (strong ion gap) and chloride levels during hospital stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ] [ Designated as safety issue: No ]
Serum creatine levels [ Time Frame: Six month control period (before) and 6 month intervention period (after) ] [ Designated as safety issue: No ]
Length of ICU stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ] [ Designated as safety issue: No ]
Length of Emergency Department stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ] [ Designated as safety issue: No ]
Length of hospital stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ] [ Designated as safety issue: No ]
In-hospital mortality [ Time Frame: Six month control period (before) and 6 month intervention period (after) ] [ Designated as safety issue: No ]

Estimated Enrollment:	7000
Study Start Date:	February 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intravenous fluids	Drug: 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.

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885404

Contacts

Contact: Rinaldo Bellomo, MD, FJFICM

rinaldo.bellomo@austin.org.au

Locations

Australia, Victoria
Austin Health	Recruiting
Melbourne, Victoria, Australia, 3084
Principal Investigator: Nor'azim Mohd Yunos, M.Anaes EDIC

Sponsors and Collaborators

Austin Health

More Information

Publications:

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. No abstract available.

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. No abstract available.

Story DA, Liskaser F, Bellomo R. Saline infusion, acidosis, and the Stewart approach. Anesthesiology. 2000 Feb;92(2):624; author reply 626. No abstract available.

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. No abstract available.

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.

Responsible Party:	Clinical Research Fellow, Department of Intensive Care, Austin Hospital. ( Nor'azim Mohd Yunos )
Study ID Numbers:	2008/03445
Study First Received:	April 21, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00885404 History of Changes
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Austin Health:

chloride
acidosis

Study placed in the following topic categories:

Shock
Critical Illness
Acidosis

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Critical Illness

ClinicalTrials.gov processed this record on August 24, 2009