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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01539551
Enrollment
300
Registered
2012-02-27
Start date
2012-02-29
Completion date
2013-01-31
Last updated
2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, 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.

Interventions

OTHERcheck BNP and lactate

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality6 monthsICU mortality, hospital mortality,

Secondary

MeasureTime frameDescription
Morbidity6 monthsAKI RIFLE stage, evidence of UGI bleeding,Ventilator days,Length of ICU stay,

Countries

Taiwan

Contacts

Primary ContactYen-Fu Chen, MD
yenfu1228@gmail.com+886-972655689

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026