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The purpose of this study is to determine the course of NT-proBNP plasma concentrations in the context of confounding parameters in postoperative/posttraumatic critically ill patients with severe SIRS/sepsis and shock.
In the recent sepsis-definitions, myocardial depression is included in the definition of severe sepsis, indicated as lowered cardiac index or echocardiographically documented cardiac dysfunction. Myocardial dysfunction occurs in greater than 50% of patients with severe sepsis and septic shock. In this context, B-type natriuretic peptid (BNP) from ventricular myocytes may serve as a surrogate biomarker for the evaluation and quantification of myocardial dysfunction. Biologically active BNP is cleaved into inactive NT-proBNP, which is supposed to be a better marker of myocardial dysfunction and prognosis in patients with severe sepsis and septic shock. However, severity of illness dependent association of myocardial dysfunction, especially left ventricular diastolic function, dosage of norepinephrine, NT-proBNP and biomarker plasma concentrations has not been systematically investigated in postoperative/posttraumatic patients in septic shock or volume-deficiency/hemorrhagic shock. Moreover, data regarding NT-proBNP plasma concentrations and renal function in postoperative/posttraumatic patients are sparse. Therefore, this prospective observational study will enroll n= 200 postoperative/posttraumatic patients to monitor longitudinally NT-proBNP, biomarkers, and cell surface markers on leukocytes to find out whether there is a discriminating pattern of myocardial dysfunction, NT-proBNP and biomarkers in patients with non-septic or septic shock, respectively, and with beneficial or harmful outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients non-septic shock | Postoperative/posttraumatic critically ill patients with non-septic shock | ||
| Patients septic shock | Postoperative/posttraumatic critically ill patients with septic shock |
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| Measure | Description | Time Frame |
|---|---|---|
| Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes | maximal NT-proBNP concentrations in critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealingnonseptic and septic shock | 01 July 2008 to 31 Dec 2008 |
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Inclusion Criteria:
Exclusion Criteria:
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Postoperative/posttraumatic critically ill patients admitted to the intensive care unit
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| Name | Affiliation | Role |
|---|---|---|
| Manfred Weiss, MD, MBA | Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Anesthesiology | Ulm | 89070 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Weiss M, Huber M, Nass M, Huber-Lang M, Koenig W, Schneider M. NT-proBNP and HMGB1 in surgical critically ill patients with hypovolemic or septic shock.Infection Suppl. II September 2011; 39: S116-117 5th International Congress of the German Sepsis Society, Weimar Sepsis Update Bridging The Gap, Weimar, 07. - 10.09.2011. | ||
| Result | Weiss M, Huber M, Nass M, Huber-Lang M, Koenig W, Schneider M. NT-proBNP serum concentrations in surgical critically ill patients with non-septic and septic shock. INNOVATIVE JOURNAL OF MEDICAL AND HEALTH SCIENCE 3 (4): 177-184, 2013. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Non-septic Shock | critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing non-septic shock |
| FG001 | Patients With Septic Shock | critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing septic shock |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
surveyed daily for sepsis, organ dysfunctions and shock
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| ID | Title | Description |
|---|---|---|
| BG000 | Postoperative/Posttraumatic Patients With Non-septic Shock | Postoperative/posttraumatic critically ill patients with non-septic shock |
| BG001 | Postoperative/Posttraumatic Patients With Septic Shock |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes | maximal NT-proBNP concentrations in critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealingnonseptic and septic shock | Posted | Median | Full Range | pg/ml | 01 July 2008 to 31 Dec 2008 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypovolemic Shock | Shock was defined as hypotension despite adequate volume resuscitation without infection, a systolic blood pressure of < 90 mmHg, or the need of vasopressors to keep blood pressure ≥ 90 mmHg. 26 patients. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Immune system disorders | Non-systematic Assessment |
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Myocardial depression has not been verified in our patients by a low cardiac index or by echocardiography
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Manfred Weiss | University | #49 731 500 60226 | manfred.weiss@uni-ulm.de |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012769 | Shock |
| D016638 | Critical Illness |
| D009102 | Multiple Organ Failure |
| D009104 | Multiple Trauma |
| D007249 | Inflammation |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D014947 | Wounds and Injuries |
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Whole blood, serum, white blood cells
Postoperative/posttraumatic critically ill patients with septic shock
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 2 |
| 26 |
| 2 |
| 26 |
| 0 |
| 26 |
| EG001 | Septic Shock | Shock was defined as hypotension despite adequate volume resuscitation due to infection, a systolic blood pressure of < 90 mmHg, or the need of vasopressors to keep blood pressure ≥ 90 mmHg. 18 patients. | 3 | 18 | 3 | 18 | 0 | 18 |
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