Critically Ill, Multiple Organ Dysfunction Syndrome, Sepsis, Shock, SIRS
Conditions
Keywords
NT-proBNP, myocardial dysfunction, humans, patients, polytrauma, complement, inflammation, inflammatory response, biomarkers, cytokines, cell surface markers, functional polymorphisms, infections, systemic inflammatory response syndrome, SIRS, sepsis, severe sepsis, shock, organ dysfunctions, SOFA, severity of disease, APACHEII, SAPSII, SPAPS3, length of stay, outcome, mortality
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Ulm
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Critically ill, postoperative/posttraumatic patients with severe systemic inflammatory response syndrome (SIRS) or severe sepsis
Exclusion criteria
* Life expectancy \< 24 hours * Participation in other trials * Known or suspected pregnancy * Contraindications for transesophageal echocardiography (TEE): severe disease of the esophagus (hernia, strictures, esophageal resection, severe bleeding disorders)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes | 01 July 2008 to 31 Dec 2008 | 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 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Postoperative/Posttraumatic Patients With Non-septic Shock Postoperative/posttraumatic critically ill patients with non-septic shock | 26 |
| Postoperative/Posttraumatic Patients With Septic Shock Postoperative/posttraumatic critically ill patients with septic shock | 18 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Postoperative/Posttraumatic Patients With Septic Shock | Postoperative/Posttraumatic Patients With Non-septic Shock | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 10 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 16 Participants | 26 Participants |
| Age, Continuous | 60 years | 53 years | 57 years |
| Region of Enrollment Germany | 18 participants | 26 participants | 44 participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 26 | 3 / 18 |
| other Total, other adverse events | 0 / 26 | 0 / 18 |
| serious Total, serious adverse events | 2 / 26 | 3 / 18 |
Outcome results
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
Time frame: 01 July 2008 to 31 Dec 2008
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Non-septic Shock | Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes | 902 pg/ml |
| Patients Septic Shock | Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes | 4,429 pg/ml |