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

NCT01539551 | Unknown

• 1 other identifier: 201111015RIB
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Mortality

  ICU mortality, hospital mortality,

  6 months

Secondary Outcomes (1)

• Morbidity

  6 months

Study Arms (1)

1

sepsis and septic shock patients

Other: check BNP and lactate

Interventions

check BNP and lactate OTHER

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe sepsis with or without septic shock

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yulin Branch

Yulin, Taiwan, 640, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood(serum/plasma)

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Lactic Acid

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Yen-Fu Chen, MD

  National Taiwan University Hospital Yulin- branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Fu Chen, MD

CONTACT

+886-972655689; yenfu1228@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: February 27, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 14, 2012

Record last verified: 2012-03

Locations

TW (1)