Crystalloid versus Albumin in the Resuscitation of Emergency Department Patients with Septic Shock

Phase 4

Withdrawn

• Conditions: Septic Shock; Infection - Other infectious diseases

• Registration Number: ACTRN12611000453987
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Infection (according to treating emergency physician’s clinical assessment)
2. Shock, as defined by either:
a. Hypotension (Systolic blood pressure <90 or Mean arterial pressure <65 despite 20ml/kg fluid bolus), or
b. Elevated lactate (arterial or venous, >4.0 mmol/l)
3. At least 2 systemic inflammatory response syndrome (SIRS) criteria present, defined as
a. Core temperature < 36.0 degrees C or > 38 degrees C
b. Heart rate > 90 beats/minute
c. Respiratory rate > 20 breaths/minute or PaC02 < 32 mmHg
d. White cell count > 12 or < 4 * 109/L

4. Antimicrobials commenced

Exclusion Criteria

1. Inter-hospital transfer
2. >8 hours in ED
3. Death is expected and imminent.
4. Underlying disease process with a life expectancy of <90 days.
5. Jehovah’s Witness
6. Age<18
7. A limitation of therapy” order has been documented restricting implementation of the study protocol or treating team clinician deems aggressive care unsuitable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Organ Dysfunction will be measured using the sequential organ dysfunction assessment tool. This tool requires clinical and laboratory based data that is obtained routinely as part of standard care.[0, 6, 24 and 72 hours after trial enrolment]

Secondary Outcome Measures

Name	Time	Method
Sublingual microcirculation will be assessed using the microvision microscan sublingual microcirculation video microscope. Four measures of microcirculation will be calculated using this equipment; capillary density, microvascular flow index, percent of perfused capillaries and perfused capillary density.[0, 6, 24 and 72 hours after trial enrolment]