Trial Outcomes & Findings for NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock (NCT NCT00736723)

NCT ID: NCT00736723

Last Updated: 2025-01-01

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 51 participants
• Primary outcome timeframe: 01 July 2008 to 31 Dec 2008
• Results posted on: 2025-01-01

Participant Flow

Participant milestones

Measure	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	Patients With Septic Shock critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing septic shock
Overall Study STARTED	30	21
Overall Study COMPLETED	26	18
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	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	Patients With Septic Shock critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing septic shock
Overall Study Withdrawal by Subject	4	3

Baseline Characteristics

NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock

Baseline characteristics by cohort

Measure	Postoperative/Posttraumatic Patients With Non-septic Shock n=26 Participants Postoperative/posttraumatic critically ill patients with non-septic shock	Postoperative/Posttraumatic Patients With Septic Shock n=18 Participants Postoperative/posttraumatic critically ill patients with septic shock	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	53 years n=5 Participants	60 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment Germany	26 participants n=5 Participants	18 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Patients Non-septic Shock n=26 Participants Postoperative/posttraumatic critically ill patients with non-septic shock	Patients Septic Shock n=18 Participants Postoperative/posttraumatic critically ill patients with septic shock
Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes	902 pg/ml Interval 39.0 to	4,429 pg/ml Interval 193.0 to

Adverse Events

Hypovolemic Shock

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Septic Shock

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Hypovolemic Shock n=26 participants at risk 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.	Septic Shock n=18 participants at risk 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.
Immune system disorders Death	7.7% 2/26 • Number of events 2	16.7% 3/18 • Number of events 3

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Manfred Weiss

University

Phone: #49 731 500 60226

Email: manfred.weiss@uni-ulm.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place