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

Completed

• Conditions: Sepsis
• Interventions: Other: Determined by intended physician

• Registration Number: NCT01362829
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2009-08
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-05-30
• Last Update Submitted: 2011-06-20
• Last Update Posted: 2011-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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Exclusion Criteria

• Patients would be excluded if they have any one of the exclusion criteria, *including pregnancy

  • presence of acute cerebral vascular attack
  • acute cardiogenic lung edema
  • status asthmatics
  • cardiac dysrhythmia as the primary diagnosis
  • massive gastrointestinal bleeding
  • epileptics
  • drug overdose
  • requirement of immediate surgery
  • hematologic malignancies
  • febrile neutropenia
  • treatment with immunosuppressive agents before admission
  • advanced malignancy and poor pre-admission performance status
  • with inevitable short-term mortality or morbidity
  • HIV infection
  • refusal of consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with severe sepsis	Determined by intended physician	Patients who are admitted to medical ICU with severe sepsis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (2)

Far Eastern Memorial Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan