NCT00619281|Completed
How Much Cardiac Output is Enough?
Prospective, Observational Study in Cardiac Surgery: How Much Cardiac Output is Enough?
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Prospective, Observational Study in Cardiac Surgery: How Much Cardiac Output is Enough?
Sponsor study identifier
Secondary identifiers
observational
600
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Low output syndrome is a common complication in patients undergoing cardiac surgery. Its incidence was reported to be 2 to 6% \[1\]. Morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense. The primary objective of this prospective observational study is to define a threshold for a critically reduced cardiac output requiring immediate therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 28, 2007
Actual (reported)February 20, 2008
Actual (reported)July 2008
Actual (reported)July 2008
Actual (reported)The primary objective is to try to define a threshold value for a critically reduced cardiac output or cardiac index requiring immediate therapy to reduce mortality and morbidity.
90 days
600 consecutive patients undergoing cardiac surgery
600 patients undergoing cardiac surgery
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
Ludwigshafen, 67063, Germany
Hausmann H, Potapov EV, Koster A, Krabatsch T, Stein J, Yeter R, Kukucka M, Sodian R, Kuppe H, Hetzer R. Prognosis after the implantation of an intra-aortic balloon pump in cardiac surgery calculated with a new score. Circulation. 2002 Sep 24;106(12 Suppl 1):I203-6.
Lehmann A, Boldt J. New pharmacologic approaches for the perioperative treatment of ischemic cardiogenic shock. J Cardiothorac Vasc Anesth. 2005 Feb;19(1):97-108. doi: 10.1053/j.jvca.2004.11.020. No abstract available.
Joachim Boldt, MD
Klinikum Ludwigshafen, Department of Anesthesiology and Intensive Care medicine
First Submitted
December 28, 2007
First Posted
February 20, 2008
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Contact the study team to confirm eligibility.
Bohrer H, Schmidt H, Motsch J, Gust R, Bach A, Martin E. Gastric intramucosal pH: a predictor of survival in cardiac surgery patients with low cardiac output? J Cardiothorac Vasc Anesth. 1997 Apr;11(2):184-6. doi: 10.1016/s1053-0770(97)90211-1.
Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901.
Adams HA, Baumann G, Gansslen A, Janssens U, Knoefel W, Koch T, Marx G, Muller-Werdan U, Pape HC, Prange W, Roesner D, Standl T, Teske W, Werner G, Zander R; I.A.G.-Schock. [Definition of shock types]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2001 Nov;36 Suppl 2:S140-3. doi: 10.1055/s-2001-18174. German.
Polonen P, Ruokonen E, Hippelainen M, Poyhonen M, Takala J. A prospective, randomized study of goal-oriented hemodynamic therapy in cardiac surgical patients. Anesth Analg. 2000 May;90(5):1052-9. doi: 10.1097/00000539-200005000-00010.
Study Completion
July 2008
Actual (reported)Last Updated
November 25, 2009
Record last verified: 2009-11
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