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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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00885404
Acronym
CHLORIDE
Enrollment
7000
Registered
2009-04-22
Start date
2009-02-28
Completion date
2010-08-31
Last updated
2010-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Shock

Keywords

chloride, acidosis

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).

Interventions

DRUGLower 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.

Sponsors

Austin Health
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean base excess during hospital staySix month control period (before) and 6 month intervention period (after)

Secondary

MeasureTime frame
Serum creatine levelsSix month control period (before) and 6 month intervention period (after)
Length of ICU staySix month control period (before) and 6 month intervention period (after)
Unmeasured anions (strong ion gap) and chloride levels during hospital staySix month control period (before) and 6 month intervention period (after)
Length of hospital staySix month control period (before) and 6 month intervention period (after)
In-hospital mortalitySix month control period (before) and 6 month intervention period (after)
Length of Emergency Department staySix month control period (before) and 6 month intervention period (after)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026