Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery
1 other identifier
observational
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 10, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 7, 2015
August 1, 2015
9 years
June 10, 2008
August 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
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)
Eligibility Criteria
Patient who need cardiac surgery and age \> 18 years
You may qualify if:
- Patient who need cardiac surgery
- Age \> 18 years
You may not qualify if:
- Patient on mechanic ventilation before surgery
- Aortic dissection-Congenital disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Chirurgie Cardio-Vasculaire au NHC, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67 091, France
Related Publications (1)
Kindo M, Minh TH, Perrier S, Petit-Eisenmann H, Bentz J, Cristinar M, Ajob G, Collange O, Mazzucotelli JP. Impact of prosthesis-patient mismatch on early haemodynamic status after aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Jan;24(1):48-54. doi: 10.1093/icvts/ivw303. Epub 2016 Sep 13.
PMID: 27624355DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel KINDO, MD
University Hospital, Strasbourg, France
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2008
First Posted
June 18, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 7, 2015
Record last verified: 2015-08