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Completed

NCT Number: NCT01362829

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Far Eastern Memorial Hospital, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Determined by intended physician

Other

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

Primary outcomes

  1. 28-day Mortality

    Time frame: 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 outcomes

  1. In-Hospital Mortality

    Time frame: 2 months

    Participants will be followed for the duration of hospital stay, an expected average of 2 months

  2. Severity of organ failure

    Time frame: 1 week

    To evaluate the development of ARDS/ALI, AKI, and the record the SOFA score

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Far Eastern Memorial Hospital

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 30, 2011
Registry last updated
Jun 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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