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

Primary Purpose

Shock, Critical Illness

Status

Unknown status

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

Lower chloride fluids (Hartmann's solution and Plasmalyte®)

About this trial

This is an interventional treatment trial for Shock focused on measuring chloride, acidosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Austin Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intravenous fluids

Arm Description

Outcomes

Primary Outcome Measures

Mean base excess during hospital stay

Secondary Outcome Measures

Unmeasured anions (strong ion gap) and chloride levels during hospital stay

Serum creatine levels

Length of ICU stay

Length of Emergency Department stay

Length of hospital stay

In-hospital mortality

Full Information

NCT ID

NCT00885404

First Posted

April 21, 2009

Last Updated

February 24, 2010

Sponsor

Austin Health

1. Study Identification

Unique Protocol Identification Number

NCT00885404

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Austin Health

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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®).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shock, Critical Illness

Keywords

chloride, acidosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

7000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous fluids

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Lower chloride fluids (Hartmann's solution and Plasmalyte®)

Other Intervention Name(s)

Plasmalyte, Lactated solution

Intervention Description

Intravenous fluids used during the 6 month intervention period (after). Amount of fluids to be used is based on clinicians' discretion.

Primary Outcome Measure Information:

Title

Mean base excess during hospital stay

Time Frame