Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01362829

Enrollment

Registered

2011-05-30

Start date

2009-08-31

Completion date

2011-05-31

Last updated

2011-06-21

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

Conditions

Sepsis

Brief summary

The investigators perform a prospective observation study to search for the outcome predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.

Detailed description

Early goal-directed therapy in patients with severe sepsis or septic shock was found to provide survival benefit.It was thought that early optimization of ScvO2 within 6 hours in emergency department brought survival benefit to patients of septic shock or severe sepsis.On the other hand, early lactate clearance is associated with improved outcome in patients with severe sepsis or septic shock. In patients with severe sepsis and septic shock, those with low lactate clearance had poor prognosis, despite optimization of ScvO2. It is unknown if ScvO2 could still guide hemodynamic resuscitation after admission into ICU. The investigators perform a prospective observation study to see the correlation between ScvO2 and clinical outcome (including organ failure, disease severity, and survival) and the correlation between lactate and clinical outcome. Furthermore, if ScvO2 \>= 70% is still of prognostic significance in ICU, we will investigate the outcome in patients with high ScvO2 and high serum lactate levels, and to evaluate the clinical features of this patient population.

Interventions

OTHERDetermined by intended physician

We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients who are admitted to medical intensive care units with severe sepsis or septic shock

Exclusion criteria

* Patients would be excluded if they have any one of the

Design outcomes

Primary

Measure	Time frame	Description
28-day Mortality	28 days	Record 28-day all-cause mortality in each population (low ScvO2, high ScvO2 and low serum lactate, high ScvO2 and high serum lactate)

Secondary

Measure	Time frame	Description
In-Hospital Mortality	2 months	Participants will be followed for the duration of hospital stay, an expected average of 2 months
Severity of organ failure	1 week	To evaluate the development of ARDS/ALI, AKI, and the record the SOFA score

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026