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

Phase 4

• Conditions: Shock; Critical Illness
• Interventions: Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®)

• Registration Number: NCT00885404
• Lead Sponsor: Austin Health

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).

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2009-08
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-24
• Last Update Posted: 2010-02-25
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7000

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intravenous fluids	Lower chloride fluids (Hartmann's solution and Plasmalyte®)	-

Primary Outcome Measures

Name	Time	Method
Mean base excess during hospital stay	Six month control period (before) and 6 month intervention period (after)

Secondary Outcome Measures

Name	Time	Method
Unmeasured anions (strong ion gap) and chloride levels during hospital stay	Six month control period (before) and 6 month intervention period (after)
Serum creatine levels	Six month control period (before) and 6 month intervention period (after)
Length of ICU stay	Six month control period (before) and 6 month intervention period (after)
Length of Emergency Department stay	Six month control period (before) and 6 month intervention period (after)
Length of hospital stay	Six month control period (before) and 6 month intervention period (after)
In-hospital mortality	Six month control period (before) and 6 month intervention period (after)

Trial Locations

Locations (1)

Austin Health; 🇦🇺 Melbourne, Victoria, Australia