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Impact of Clinical, Demographic and Laboratory Variables on Brain Natriuretic Peptide Levels

This study has been withdrawn prior to enrollment.
(No Patients were recruited during the study period)
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01382394
First received: June 23, 2011
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

Brain natriuretic peptide (BNP) is involved in the regulation of blood pressure and fluid volume. It is used for the early diagnosis of heart failure (HF) in patients presenting to the emergency room with dyspnea. Interleukin-6 (IL-6) is a cytokine marker of inflammation that exhibits significant prognostic value in predicting severity and outcome of sepsis. Recently, it was suggested that inflammatory cytokines play an important role in the development of heart failure. Procalcitonin (PCT) is a propeptide of calcitonin which is normally produced in the C-cells of the thyroid glands. Although physiologic levels of PCT remain very low, a dramatic increase in serum PCT levels is observed during severe systemic infections. These properties make procalcitonin less useful for the diagnosis of simple infections but a very promising marker of severe infections especially in the critical care setting.

To investigate the co-relation between BNP, IL-6 and procalcitonin in two groups of patients; those presenting with the diagnosis of decompensated heart failure and in patients presenting with the diagnosis of sepsis without cardiovascular or hemodynamic dysfunction.


Condition
Sepsis
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Clinical, Demographic and Laboratory Variables on Brain Natriuretic Peptide Levels

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Enrollment: 60
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sepsis Group, Heart failure group

The first group will include 60 patients with the diagnosis of acute decompensated heart failure.

The second group will include 60 patients with the diagnosis of sepsis.


Detailed Description:

Brain natriuretic peptide (BNP), forms together with atrial natriuretic peptide (ANP) a peptide family involved in the regulation of blood pressure and fluid volume. It is used for the early diagnosis of heart failure (HF) in patients presenting to the emergency room with dyspnea. Additionally, in patients with chronic HF and acute and chronic coronary syndrome, BNP is a marker of unfavorable prognosis, being associated with increased mortality.

Recently, elevated BNP levels have been measured in patients with septic shock and have been attributed to myocardial dysfunction due to sepsis. Because BNP synthesis is also induced by endotoxin and inflammatory mediators, the mechanisms leading to elevated BNP levels in patients with sepsis remain unclear.

Interleukin-6 (IL-6) is a cytokine marker of inflammation that exhibits significant prognostic value in predicting severity and outcome of sepsis, since it is considered to play a key role in the pathogenesis of sepsis. Accumulating evidence suggests that inflammatory cytokines play an important role in the development of heart failure. In particular, studies using genetically engineered animal models have demonstrated the critical role of the gp130-dependent cardiomyocyte survival pathway in the transition to heart failure. However, the significance of gp130 for patients with CHF has not been fully assessed. Previous clinical studies showed that the plasma level of IL-6 is elevated in patients with advanced CHF and that such high levels are associated with a poor prognosis for CHF patients.

Procalcitonin (PCT) is a propeptide of calcitonin which is normally produced in the C-cells of the thyroid glands. Although physiologic levels of PCT remain very low, a dramatic increase in serum PCT levels is observed during severe systemic infections. It is not infection per se but infection accompanied by severe systemic reactions or poor organ perfusion that increases procalcitonin levels. These properties make procalcitonin less useful for the diagnosis of simple infections but a very promising marker of severe infections especially in the critical care setting.

Few studies have investigated the role of procalcitonin in patients with acute heart failure, although there was a slightly increased level of procalcitonin in patients with severe acute heart failure, the results were not conclusive. These results support the hypothesis that inflammatory process has a role in heart failure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will be performed at Rambam Medical Center, Israel. Patients admitted to the department of internal medicine will be divided to two groups

Criteria

Inclusion Criteria:

  • 1) Patients with decompensated heart failure (N-60).
  • 2) Patients with sepsis (N-60).

Exclusion Criteria:

  • 1) Patients who are under the age of 18 years
  • 2) pregnant women.
  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: NCT01382394

Locations
Israel
Internal Medicine "B", Rambam Medical center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Chair: Zaher S Azzam, MD Head Of Internal Medicine "B"
  More Information

No publications provided

Responsible Party: Rambam Medical Center, Zaher S. Azzam M.D.
ClinicalTrials.gov Identifier: NCT01382394     History of Changes
Other Study ID Numbers: 0459-09-RMB
Study First Received: June 23, 2011
Last Updated: August 3, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
Sepsis
heart failure
BNP
IL-6
Procalcitonin
Prognosis

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014