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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01539551
First received: February 21, 2012
Last updated: November 12, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    ICU mortality, hospital mortality,


Secondary Outcome Measures:
  • 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
Study Population

Severe sepsis with or without septic shock

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539551

Contacts
Contact: Yen-Fu Chen, MD +886-972655689 yenfu1228@gmail.com

Locations
Taiwan
National Taiwan University Hospital Yulin Branch Recruiting
Yulin, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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
Shock
Shock, Septic
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014