Clinical trial NCT01539551: Investigation of the Role of Brain Natriuretic Peptide and Lactate in Early Goal-directed Therapy for Patients With Severe Sepsis and Septic Shock
Official title: Investigation of the Role of Brain Natriuretic Peptide and Lactate in Early Goal-directed Therapy for Patients With Severe Sepsis and Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-02-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe sepsis with or without septic shock

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
measure: Morbidity
timeFrame: 6 months
Other outcomes:
Locations:
city: Yulin
country: Taiwan
facility: National Taiwan University Hospital Yulin Branch
Study officials:
affiliation: National Taiwan University Hospital Yulin- branch
name: Yen-Fu Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: