Artificial organs
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Randomized Controlled Trial Clinical Trial
U.S. clinical studies of the treatment of anemia with fluosol-DA 20%.
This article describes the progress of clinical studies of the perfluorochemical (PFC) emulsion Fluosol-DA 20% in the United States. To date, two studies have been completed and one is in progress. All three studies have been restricted to the treatment of acute anemia in patients who refused blood transfusions on religious grounds, i.e., Jehovah's Witnesses. ⋯ This increased oxygen transport by the PFC resulted in increased oxygen consumption and arterial and mixed venous blood oxygenation. Two of the seven patients had adverse reactions to a 0.5-ml test dose of Fluosol, manifested by an increase in pulmonary artery systolic pressure. The third and current anemia protocol as of this writing is a randomized controlled study with data collection similar to the Medical Use Protocol.(ABSTRACT TRUNCATED AT 250 WORDS)
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Thirty-five patients undergoing open-heart surgery are reported. Cardiac index, mean arterial pressure, oxygen consumption, lactate, pyruvate, and lactate excess in the blood were measured. An inverse correlation of arterial pressure with oxygen consumption and lactate excess was found during perfusion. ⋯ These parameters determined the level of "hypoxic" lactate concentration as well as arterial pressure during perfusion. These data appear to suggest that during perfusion the severity of metabolic disturbances determines the level of arterial pressure rather than vice versa. Arterial pressure and oxygen consumption, thus, cannot be applied as general criteria of the adequacy of extracorporeal circulation.
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This study attempts to quantitate post-infarction cardiogenic shock IABP dependence in instances of massive myocardial infarction with the use of hemodynamic indices plotted over time-course trajectories. Mortality is predicted when age and hemodynamic performance are also considered. ⋯ They do not expire during the first 50 hours of IABP support and neither improve nor deteriorate during the second 50 hours of support. They remain in Class B without the occurrence of life-threatening ventricular dysrhythmias for a sufficient time for cardiac catheterization to determine the appropriateness of corrective procedures.
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Randomized Controlled Trial Clinical Trial
Hematologic observations made in patients with acute respiratory distress syndrome in the cooperative ECMO project.
In a recently completed three-year multicenter trial, 90 individuals with adult acute respiratory distress syndrome (ARDS) were randomly allocated to conventional therapy with or without long-term extracorporeal membrane oxygenation (ECMO). This study conclusively demonstrated that ARDS is associated with frequent major bleeding and thrombotic episodes and that the bleeding correlates best with the degree of thrombocytopenia and is enhanced by the machine. Neither heparin's therapeutic efficacy nor its ability to increase bleeding could be proven. ⋯ Besides thrombocytopenia, there were lowered circulating levels of factors VII and XII which may be related to changes in the pulmonary endothelium. ECMO was associated with relative leukopenia and a marked shift to immature circulating leukocytes. Further studies are needed to better define the clinical importance of thrombosis and bleeding in the lung, the role for heparin in treatment, and the meaning of reductions in coagulation factors in defining the course, prognosis and response to therapy of patients with ARDS.