A pilot, randomized, blinded, multi-centre, feasibility, safety and biochemical and physiological study of normal saline versus plasmalyte in intensive therapy

Phase 2

Completed

• Conditions: Critical Illness; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12615000158561
• Lead Sponsor: Austin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients aged 18 years or older admitted to study ICU’s who receive any crystalloid fluid resuscitation.

Exclusion Criteria

1. Patients who are transferred from another hospital to a study ICU in order to receive renal replacement therapy for acute kidney injury
2. Patients who are admitted to the ICU for consideration of organ donation.
3. Patients admitted to ICU after cardiac surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Base excess as obtained from routine pathology testing and assessed via medical record review[Daily from ICU admission until day four of ICU care.]

Secondary Outcome Measures

Name	Time	Method
Acute kidney injury as per the RIFLE criteria as obtained from routine pathology testing and assessed via medical record review[Daily changes in the patient's serum creatinine, serum chloride and urinary output occurring from the admission to ICU until ICU discharge];Delta creatine (the difference between baseline and peak creatinine) as determined by medical record review[Daily from ICU admission until ICU discharge];Requirement for renal replacement therapy assessed via medical record review[Daily from admission to ICU through to discharge from ICU];Mortality - intensive care unit assessed via medical record review[Daily from ICU admission until ICU discharge];Mortality - hospital assessed via medical record review[Daily from hospital admission until hospital discharge]