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Status unknownNCT01539551Updated Nov 14, 2012

Investigation of the Role of Brain Natriuretic Peptide and Lactate in Early Goal-directed Therapy for Patients With Severe Sepsis and Septic Shock

An observational study in Sepsis and Septic Shock, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-14.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

B-type natriuretic peptide (BNP) is a cardiac neurohormone which rapidly released by the ventricle in response to myocardial stretch. BNP has been used as a biomarker of sepsis related cardiac dysfunction and volume overload in critical ill patients. It is also a marker associated with prognosis in patients with severe sepsis and septic shock. However, the clinical utility of BNP level in management of early severe sepsis and septic shock over the first 48 hours is not clear. Besides, Lactate represents as a maker of tissue hypoperfusion, which has been used as a guide therapy for sepsis patients and high serum lactate level is independently associated with mortality in severe sepsis. Today, in management of early severe sepsis and septic shock, current guideline emphasize the early goal-directed therapy (EGDT) with achieving the central venous pressure (CVP) level 8-12 mmHg by fluid support first, then targeting the next goal to maintain mean airway pressure (MAP) at least 65 mmHg by vasopressor agent (ie, Norepinephrine) and finally keeping central venous oxyhemoglobin saturation (ScvO2) > 70% via optimal Hct > 30% and dobutamine usage within first 6 hours of emergency department admission. However, the role of BNP and lactate in patients with severe sepsis and septic shock with or without myocardial dysfunction under EGDT management are not clear.

The investigators will conduct a prospective observational study to investigate the change of BNP and Lactate within 48 hours in early severe sepsis and septic shock under EGDT management, their association of cardiac dysfunction and their role in predicting various clinical outcome. The investigators also want to see if BNP and lactate could be useful tools to guide the adjustment of optimal fluid supply and the timing of inotropic agent intervention.

02

Conditions studied

  • Sepsis
  • Septic Shock
03

In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's planned enrollment of 300 is above the median of 160 across 957 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,608 studies on the registry; 573 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Severe sepsis with or without septic shock

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients > 18 years old
  • Severe sepsis with or without septic shock

Exclusion criteria

Exclusion Criteria:

  1. Previous known heart failure or cardiomyopathy history
  2. Acute coronary syndrome
  3. Clinical pulmonary hypertension with various cause (iPAH, congenital heart disease, CTEPH, COPD with cor pulmonale)
  4. Patients with acute pulmonary embolism
  5. Chronic Af with LVH
  6. Acute cerebral vascular event
  7. Respiratory failure with high PEEP > 10 cmH2O)
  8. Various cancer with distant metastasis
  9. Patients with Bosmin therapy
  10. Patients received CPR (IHCA or OHCA)
  11. Massive GI bleeding or hypovolemic shock
  12. Pregnancy
  13. Contraindication to central venous catheterization
  14. Drug overdose
  15. Burn injury, trauma patients
  16. A requirement for immediate surgery
  17. Liver cirrhosis child C
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 1

    sepsis and septic shock patients

    Other: check BNP and lactate

Interventions

  • Othercheck BNP and lactate

    we will collect patients's blood samples on Day 0, Day1 and Day2

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What researchers measure

Primary outcomes

  1. Mortality

    ICU mortality, hospital mortality,

    Time frame: 6 months

Secondary outcomes

  1. Morbidity

    AKI RIFLE stage, evidence of UGI bleeding,Ventilator days,Length of ICU stay,

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital Yulin Branch
    Yulin, Taiwan 640, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01539551
Responsible party
Sponsor
First posted
Feb 27, 2012
Start date
Feb 2012
Primary completion
Jan 2013 (estimated)
Completion
Jan 2013 (estimated)
Last update
Nov 14, 2012

Study contacts

Yen-Fu Chen, MD
Contact
yenfu1228@gmail.com
+886-972655689
Yen-Fu Chen, MD
principal investigator · National Taiwan University Hospital Yulin- branch

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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