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Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation (CHLORIDE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Austin Health.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885404
First Posted: April 22, 2009
Last Update Posted: February 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Austin Health
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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) ]

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) ]
  • Serum creatine levels [ Time Frame: Six month control period (before) and 6 month intervention period (after) ]
  • Length of ICU stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ]
  • Length of Emergency Department stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ]
  • Length of hospital stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ]
  • In-hospital mortality [ Time Frame: Six month control period (before) and 6 month intervention period (after) ]

Estimated Enrollment: 7000
Study Start Date: February 2009
Estimated Study Completion Date: August 2010
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.
Other Names:
  • Plasmalyte
  • Lactated solution

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Exclusion Criteria: Nil

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885404


Locations
Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health
Investigators
Principal Investigator: Nor'azim Mohd Yunos, MBBS Department of Intensive Care, Austin Health
  More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nor'azim Mohd Yunos, Clinical Research Fellow, Department of Intensive Care, Austin Hospital.
ClinicalTrials.gov Identifier: NCT00885404     History of Changes
Other Study ID Numbers: 2008/03445
First Submitted: April 21, 2009
First Posted: April 22, 2009
Last Update Posted: February 25, 2010
Last Verified: February 2010

Keywords provided by Austin Health:
chloride
acidosis

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Plasma-lyte 148
Pharmaceutical Solutions
Ophthalmic Solutions