Tissue oxygenation in early sepsis study

Not Applicable

Completed

• Conditions: Sepsis; Infection - Other infectious diseases

• Registration Number: ACTRN12612001229864
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Suspected or proven infection plus 2 or more of (i) temperature >38 of <36 degrees celsius (ii) heart rate >90bpm (iii) respiratory rate >20/min (iv) total white blood count >12x109/L or <4x109/L, and being admitted to hospital for intravenous antibiotics.

Patients will be included if they meet criteria for uncomplicated sepsis, severe sepsis (associated with organ dysfunction) and/or septic shock. Criteria for severe sepsis or septic shock as follows:

Case definition for sepsis as above PLUS either -
1. Organ failure defined as SOFA score of 2 or more e.g. acute respiratory failure, renal failure, or altered mental state
2. Shock defined as (a)systolic blood pressure (SBP) <90mmHg, or mean arterial pressure (MAP)<65mmHg or heart rate >SBP (shock index >1) despite 20-30ml/kg isotonic fluid bolus or (b) serum lactate >4mmol/L.

Exclusion Criteria

Age <18 years
Expected to die from other cause (e.g. malignancy) within 90 days
Diagnosed significant chronic cognitive impairment (MMSE<21)
Not for resuscitation order
Intravenous antibiotics prior to presentation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Organ failure defined using sequential organ failure assessment (SOFA) score of 2 or more points increase from baseline[Once daily SOFA score up to 72 hours following admission from Emergency Department or discharge/death if earlier];Peak, mean and delta (maximal change from admission) SOFA score[Once daily SOFA score up to 72 hours following admission from Emergency Department or discharge/death if earlier]

Secondary Outcome Measures

Name	Time	Method
Death (all cause) as determined from hospital patient database (which is updated from the state register of Births, Deaths and marriages) hospital medical records or contact with the patients primary care doctor as necessary.[28 days];Subgroup analysis of organ failure (SOFA score of 2 or more) developing among patients with no organ failure or shock present at enrolment[Once daily SOFA score up to 72 hours following admission from Emergency Department or discharge/death if earlier];Subgroup analysis of peak, mean and delta SOFA score among patients with organ failure/shock present at enrolment[Once daily SOFA score up to 72 hours following admission from Emergency Department or discharge/death if earlier]