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

Critical Illness Clinical Trial

— CHLORIDE  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00885404
• Other study ID #: 2008/03445
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 21, 2009
• Last updated: February 24, 2010
• Start date: February 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2010
• Source: Austin Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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®).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7000
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Shock

Intervention

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.

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Austin Health

Country where clinical trial is conducted

Australia, 

References & Publications (13)

Constable PD. Hyperchloremic acidosis: the classic example of strong ion acidosis. Anesth Analg. 2003 Apr;96(4):919-22. Review. — View 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. — View Citation

Dorje P, Adhikary G, Tempe DK. Avoiding latrogenic hyperchloremic acidosis--call for a new crystalloid fluid. Anesthesiology. 2000 Feb;92(2):625-6. — View 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. — View 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. Epub 2004 Feb 28. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Story DA, Liskaser F, Bellomo R. Saline infusion, acidosis, and the Stewart approach. Anesthesiology. 2000 Feb;92(2):624; author reply 626. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean base excess during hospital stay		Six month control period (before) and 6 month intervention period (after)	No
Secondary	Unmeasured anions (strong ion gap) and chloride levels during hospital stay		Six month control period (before) and 6 month intervention period (after)	No
Secondary	Serum creatine levels		Six month control period (before) and 6 month intervention period (after)	No
Secondary	Length of ICU stay		Six month control period (before) and 6 month intervention period (after)	No
Secondary	Length of Emergency Department stay		Six month control period (before) and 6 month intervention period (after)	No
Secondary	Length of hospital stay		Six month control period (before) and 6 month intervention period (after)	No
Secondary	In-hospital mortality		Six month control period (before) and 6 month intervention period (after)	No