NICUPS: NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock

• Sponsor: University of Ulm (Other)
• Overall Status: Completed
• CT.gov ID: NCT00736723
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Duration (Months): 52
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SIRS; Sepsis; Shock; Critically Ill; Multiple Organ Dysfunction Syndrome

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: NT-proBNP in Postoperative/Posttraumatic Critically Ill Patients With Severe SIRS/Sepsis and Shock
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Patients non-septic shock Postoperative/posttraumatic critically ill patients with non-septic shock
Patients septic shock Postoperative/posttraumatic critically ill patients with septic shock

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic of Anesthesiology	Ulm		Germany	89070

Sponsors and Collaborators

• University of Ulm

Investigators

• Principal Investigator: Manfred Weiss, MD, MBA, Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manfred Weiss, Professor, MD, MBA, University of Ulm
• ClinicalTrials.gov Identifier: NCT00736723
• Other Study ID Numbers: Anae_ICU_Ulm_NT-proBNP
• First Posted: Aug 18, 2008
• Last Update Posted: Jan 20, 2017
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Manfred Weiss, Professor, MD, MBA, University of Ulm: 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
• Additional relevant MeSH terms: Sepsis; Toxemia; Shock; Critical Illness; Multiple Organ Failure

Study Results

Participant Flow

Arm/Group Title	Patients With Non-septic Shock	Patients With Septic Shock
Arm/Group Description	critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing non-septic shock	critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing septic shock
Period Title: Overall Study
STARTED	30	21
COMPLETED	26	18
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Postoperative/Posttraumatic Patients With Non-septic Shock	Postoperative/Posttraumatic Patients With Septic Shock	Total
Arm/Group Description	Postoperative/posttraumatic critically ill patients with non-septic shock	Postoperative/posttraumatic critically ill patients with septic shock	Total of all reporting groups
Overall Participants	26	18	44
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 61.5%	10 55.6%	26 59.1%
>=65 years	10 38.5%	8 44.4%	18 40.9%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	53	60	57
Gender (Count of Participants)
Female	7 26.9%	2 11.1%	9 20.5%
Male	19 73.1%	16 88.9%	35 79.5%
Region of Enrollment (participants) [Number]
Germany	26 100%	18 100%	44 100%

Outcome Measures

1. Primary Outcome

Title	Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Non-septic Shock	Patients Septic Shock
Arm/Group Description	Postoperative/posttraumatic critically ill patients with non-septic shock	Postoperative/posttraumatic critically ill patients with septic shock
Measure Participants	26	18
Median (Full Range) [pg/ml]	902	4,429

Adverse Events

Arm/Group Title	Postoperative/Posttraumatic Patients With Non-septic Shock		Postoperative/Posttraumatic Patients With Septi
Arm/Group Description	Postoperative/posttraumatic critically ill patients with non-septic shock		Postoperative/posttraumatic critically ill patients with septic shock
All Cause Mortality
	Postoperative/Posttraumatic Patients With Non-septic Shock		Postoperative/Posttraumatic Patients With Septi
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Postoperative/Posttraumatic Patients With Non-septic Shock		Postoperative/Posttraumatic Patients With Septi
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Postoperative/Posttraumatic Patients With Non-septic Shock		Postoperative/Posttraumatic Patients With Septi
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/18 (0%)

Limitations/Caveats

Myocardial depression has not been verified in our patients by a low cardiac index or by echocardiography

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.