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

NCT ID: NCT01362829

Last Updated: 2011-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-05-31

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.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with severe sepsis

Patients who are admitted to medical ICU with severe sepsis

Determined by intended physician

Intervention Type: OTHER

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

Interventions

Determined by intended physician

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Hospital

Principal Investigators

Chong-Jen Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Hou-Tai Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Locations

Far Eastern Memorial Hospital

Taipei, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

098014-3

Identifier Type: OTHER

Identifier Source: secondary_id

200907064R

Identifier Type: -

Identifier Source: org_study_id