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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Shock, Critical Illness

Intervention / Treatment
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* Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intravenous fluids<br> | Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®)<br>* Intravenous fluids used during the 6 month intervention period (after). Amount of fluids to be used is based on clinicians' discretion.<br>* Other names: Lactated solution;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chloride, acidosis