Overview

This trial is active, not recruiting.

Conditions shock, critical illness
Treatment lower chloride fluids (hartmann's solution and plasmalyte®)
Phase phase 4
Sponsor Austin Health
Start date February 2009
End date August 2009
Trial size 7000 participants
Trial identifier NCT00885404, 2008/03445

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®).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Other)
lower chloride fluids (hartmann's solution and plasmalyte®) Plasmalyte
Intravenous fluids used during the 6 month intervention period (after). Amount of fluids to be used is based on clinicians' discretion.

Primary Outcomes

Measure
Mean base excess during hospital stay
time frame: Six month control period (before) and 6 month intervention period (after)

Secondary Outcomes

Measure
Unmeasured anions (strong ion gap) and chloride levels during hospital stay
time frame: 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)
Length of ICU stay
time frame: 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)
Length of hospital stay
time frame: 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)

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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.
Principal investigator Nor'azim Mohd Yunos, MBBS
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).
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Austin Health.