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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Austin Health.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Austin Health
ClinicalTrials.gov Identifier:
NCT00885404
First received: April 21, 2009
Last updated: February 24, 2010
Last verified: February 2010

April 21, 2009
February 24, 2010
February 2009
August 2009   (final data collection date for primary outcome measure)
Mean base excess during hospital stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00885404 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation
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.

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®).

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).

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Shock
  • Critical Illness
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
Intravenous fluids
Intervention: Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
7000
August 2010
August 2009   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00885404
2008/03445
No
Nor'azim Mohd Yunos, Clinical Research Fellow, Department of Intensive Care, Austin Hospital.
Austin Health
Not Provided
Principal Investigator: Nor'azim Mohd Yunos, MBBS Department of Intensive Care, Austin Health
Austin Health
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP