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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Septic Shock
• Intervention / Treatment: Other: check BNP and lactate

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Taiwan
  • Yulin, Taiwan, 640
    • Recruiting
    • National Taiwan University Hospital Yulin Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Severe sepsis with or without septic shock

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; sepsis and septic shock patients	Other: check BNP and lactate; we will collect patients's blood samples on Day 0, Day1 and Day2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	ICU mortality, hospital mortality,	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	AKI RIFLE stage, evidence of UGI bleeding,Ventilator days,Length of ICU stay,	6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yen-Fu Chen, MD, National Taiwan University Hospital Yulin- branch

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ANTICIPATED): January 1, 2013
• Study Completion (ANTICIPATED): January 1, 2013

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (ESTIMATE): February 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 12, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Shock, Septic; Shock
• Other Study ID Numbers: 201111015RIB