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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00699673
Other study ID # 3910
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 10, 2008
Last updated August 6, 2015
Start date June 2008
Est. completion date June 2017

Study information

Verified date August 2015
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

Objective: The purpose of the present study is to assess if perioperative variation of Brain Natriuretic Peptide (BNP) levels is a predictor of mortality and morbidity after cardiac surgery.Material and Methods: 500 consecutive patients will be enrolled prospectively in this study before cardiac surgery under cardiopulmonary bypass. BNP levels will be measured prior to surgery and at postoperative day 1. Variations of BNP levels will be analyzed to determine if it is a predictor of mortality and morbidity after cardiac surgery. This dynamic evaluation will be compared to other tools of risk stratification in cardiac surgery as the EuroScore. All patients will be followed 3 years after the procedure.

Hypothesis: Perioperative BNP variations may be more sensitive than pre- or postoperative BNP levels alone. Furthermore the perioperative homeostasis will be measured to assess its impact on BNP secretion during the perioperative period.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient who need cardiac surgery

- Age > 18 years

Exclusion Criteria:

- Patient on mechanic ventilation before surgery

- Aortic dissection-Congenital disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
France Service de Chirurgie Cardio-Vasculaire au NHC, Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary BNP levels; hospital and long-term morbidity and mortality BNP levels prior to surgery and at postoperative day 1; Hospital and long-term morbidity and mortality (1, 2 and 3 years) No
Secondary EuroScoreCardiac markers; inflammation markers; echocardiography EuroScoreCardiac markers at day 1, 2, 5; Inflammation markers at day 1, 2, 5; Echocardiography (day 5, and 1, 2 and 3 years) No
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