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Is There a Correlation of Natriuretic Propeptide Type B With an Intraoperative Low Cardiac Output?

This study has been completed.
Sponsor:
Information provided by:
Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:
NCT00586027
First received: December 21, 2007
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

Low output syndrome is a common complication in patients undergoing cardiac surgery. Its incidence was reported to be 2 to 6%. Morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense.Natriuretic propeptide Type B (NT-proBNP) is a biological marker for the diagnosis, prognosis and therapy of cardiac failure after cardiac surgery.

Cardiac index and NT-proBNP will be correlated with morbidity and mortality. A critical threshold value for intraoperative cardiac index and NT-proBNP will be calculated.


Condition
Cardiac Surgery
Low Cardiac Output
Natriuretic Peptide B

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Observational Study in Patients Undergoing Cardiac Surgery: Part 2: Is There a Correlation of Natriuretic Propeptide Type B With an Intraoperative Low Cardiac Output?

Resource links provided by NLM:


Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:
  • The primary objective is to monitor NT-proBNP for 7 days in patients with an intraoperative low cardiac output. Cardiac index and NT-proBNP will be correlated with morbidity and mortality. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
NT-proBNP
150 consecutive patients undergoing cardiac surgery with an intraoperative measured cardiac output <2L/min/m².

Detailed Description:

Low output syndrome is a common complication in patients undergoing cardiac surgery. Its incidence was reported to be 2 to 6% [1]. In patients suffering from low output syndrome cardiac output is severely reduced due to myocardial failure. Among other reasons for myocardial failure, ischemia, insufficient myocardial protection during aortic cross-clamping, and severely reduced ventricular function prior surgery are the most common risk factors for low output syndrome. Low output syndrome is treated with positive inotropic drugs and mechanical assist devices [2]. Morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense.

If cardiac output cannot be increased cardiac failure persist and vital organs are hypoperfused. Critical and prolonged hypoperfusion results in single and multi organ failure. Until today a definite threshold for a critically reduced cardiac output or cardiac index requiring immediate therapy is not completely known. Cardiogenic shock is diagnosed by clinical signs and it is not diagnosed by cardiac output or cardiac index. The critical value for a severely reduces cardiac index was reported to be in a range of 1.75 to 2.5L/min/m² [3-5].

Natriuretic propeptide Type B (NT-proBNP) is a biological marker for the diagnosis, prognosis and therapy of cardiac failure after cardiac surgery [6,7].

The primary objective of this prospective observational study in 150 patients undergoing cardiac surgery with an intraoperative measured cardiac output <2L/min/m² is to monitor NT-proBNP for 7 days. Cardiac index and NT-proBNP will be correlated with morbidity and mortality [8]. A critical threshold value for intraoperative cardiac index and NT-proBNP will be calculated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

150 patients undergoing cardiac surgery, being monitored with a Swan-Ganz catheter and an intraoperatively before cardiopulmonary bypass measured cardiac index <2L/min/m².

Criteria

Inclusion Criteria:

  • Adult patient undergoing cardiac surgery
  • Written informed consent
  • Cardiac index before cardiopulmonary bypass <2L/min/m²

Exclusion Criteria:

  • Missing consent
  • Serum creatinine >1.5mg/dL [>123µmol/L]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586027

Locations
Germany
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
Ludwigshafen, Germany, 67063
Sponsors and Collaborators
Klinikum Ludwigshafen
Investigators
Principal Investigator: Andreas Lehmann, MD Klinikum der Stadt Ludwigshafen, Departement of Anesthesiology and Intensive Care Medicine
  More Information

Publications:

Responsible Party: Dr Andreas Lehmann, Klinikum der Stadt Ludwigshafen, Department of Anaesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00586027     History of Changes
Other Study ID Numbers: CI/NT-proBNP-12-2007
Study First Received: December 21, 2007
Last Updated: November 23, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum Ludwigshafen:
cardiac surgery
low cardiac output
natriuretic peptide B
mortality
morbidity

Additional relevant MeSH terms:
Cardiac Output, Low
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014