NCT00736723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

August 14, 2008

Results QC Date

December 2, 2015

Last Update Submit

December 9, 2024

Conditions

Keywords

NT-proBNPmyocardial dysfunctionhumanspatientspolytraumacomplementinflammationinflammatory responsebiomarkerscytokinescell surface markersfunctional polymorphismsinfectionssystemic inflammatory response syndromeSIRSsepsissevere sepsisshockorgan dysfunctionsSOFAseverity of diseaseAPACHEIISAPSIISPAPS3length of stayoutcomemortality

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients non-septic shock

Postoperative/posttraumatic critically ill patients with non-septic shock

Patients septic shock

Postoperative/posttraumatic critically ill patients with septic shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Postoperative/posttraumatic critically ill patients admitted to the intensive care unit

You may qualify if:

  • Critically ill, postoperative/posttraumatic patients with severe systemic inflammatory response syndrome (SIRS) or severe sepsis

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Anesthesiology

Ulm, 89070, Germany

Location

Related Publications (2)

  • 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.

    RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, white blood cells

MeSH Terms

Conditions

SepsisShockCritical IllnessMultiple Organ FailureMultiple TraumaInflammationInfectionsSystemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesWounds and Injuries

Limitations and Caveats

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

Results Point of Contact

Title
Prof. Dr. Manfred Weiss
Organization
University

Study Officials

  • Manfred Weiss, MD, MBA

    Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, MBA

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 18, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

January 1, 2025

Results First Posted

January 20, 2017

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations