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

February 24, 2010 updated by: Austin Health

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®).

Study Overview

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).

Study Type

Interventional

Enrollment (Anticipated)

7000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Melbourne, Victoria, Australia, 3084
        • Austin Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intravenous fluids
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean base excess during hospital stay
Time Frame: Six month control period (before) and 6 month intervention period (after)
Six month control period (before) and 6 month intervention period (after)

Secondary Outcome Measures

Outcome Measure
Time Frame
Unmeasured anions (strong ion gap) and chloride levels during hospital stay
Time Frame: Six month control period (before) and 6 month intervention period (after)
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)
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)
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)
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)
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)
Six month control period (before) and 6 month intervention period (after)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Nor'azim Mohd Yunos, MBBS, Department of Intensive Care, Austin Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (Estimate)

April 22, 2009

Study Record Updates

Last Update Posted (Estimate)

February 25, 2010

Last Update Submitted That Met QC Criteria

February 24, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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