Investigation of the Role of Brain Natriuretic Peptide and Lactate in Early Goal-directed Therapy for Patients With Severe Sepsis and Septic Shock
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sepsis Septic Shock |
Other: check BNP and lactate |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]ICU mortality, hospital mortality,
- Morbidity [ Time Frame: 6 months ] [ Designated as safety issue: No ]AKI RIFLE stage, evidence of UGI bleeding,Ventilator days,Length of ICU stay,
Biospecimen Retention: Samples Without DNA
blood(serum/plasma)
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
sepsis and septic shock patients
|
Other: check BNP and lactate
we will collect patients's blood samples on Day 0, Day1 and Day2
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Severe sepsis with or without septic shock
Inclusion Criteria:
- Patients > 18 years old
- Severe sepsis with or without septic shock
Exclusion Criteria:
- Previous known heart failure or cardiomyopathy history
- Acute coronary syndrome
- Clinical pulmonary hypertension with various cause (iPAH, congenital heart disease, CTEPH, COPD with cor pulmonale)
- Patients with acute pulmonary embolism
- Chronic Af with LVH
- Acute cerebral vascular event
- Respiratory failure with high PEEP > 10 cmH2O)
- Various cancer with distant metastasis
- Patients with Bosmin therapy
- Patients received CPR (IHCA or OHCA)
- Massive GI bleeding or hypovolemic shock
- Pregnancy
- Contraindication to central venous catheterization
- Drug overdose
- Burn injury, trauma patients
- A requirement for immediate surgery
- Liver cirrhosis child C
Contacts and Locations| Contact: Yen-Fu Chen, MD | +886-972655689 | yenfu1228@gmail.com |
| Taiwan | |
| National Taiwan University Hospital Yulin Branch | Recruiting |
| Yulin, Taiwan, 640 | |
| Principal Investigator: | Yen-Fu Chen, MD | National Taiwan University Hospital Yulin- branch |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01539551 History of Changes |
| Other Study ID Numbers: | 201111015RIB |
| Study First Received: | February 21, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Sepsis Toxemia Shock Shock, Septic Infection Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Natriuretic Peptide, Brain Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013