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Biomedical subjects

K W von Eickstedt

Publications and source records attributed to K W von Eickstedt.

14 recordsLinked to original sources

The ethical position of the attending physician in Phase III of clinical investigations.

The ethical position of the attending physician in Phase III of a clinical trial differs from his position in the other two phases. In Phase II he normally presupposes that the new drug has a priority as regards one or more therapeutic properties compared with the already known drug, which he uses as the control. Phase III is based on the results of the Phase II investigations; thus the drug has been proven to be effective therapeutically before Phase III begins. The patients have to be informed about the properties of the drug to be tested. The position of the physician informing them is explained and discussed with respect to the differences between the new and the old drug.

Clinical Trials as Topic↗

[Evaluation of side effects].

The calculation of the benefit-risk-ratio of drugs is discussed on the basis of examples of side effects of different grades of severity. The 4 categories of side effects which are more difficult to be evaluated. The "Stufenplan" is described, which is used for the coordination of necessary preventive measures when side effects of drugs are noticed.

Aerosols↗

Urodilatin, a new therapy to prevent kidney failure after heart transplantation.

Kidney failure after heart transplantation still remains a crucial problem, especially when cyclosporine is used for early postoperative immunosuppressive therapy. To preserve good renal function during immunosuppression with cyclosporine, urodilatin (CDD/ANP-95-126), the kidney-born analogue to the circulating cardiac peptide hANP (CDD/ANP-99-126), was given for the first time as a long-term, low-dose infusion in addition to the usual drug therapy immediately after heart transplantation. From November 1990 to January 1992, 47 patients (44 men and three women; mean age, 51 years) were treated by a 20 ng/kg body weight/min infusion for 96 hours after heart transplantation. Renal function and hemodynamic parameters of these patients were compared with a group of 40 patients (34 male and six female; mean age, 50 years) as controls, who underwent heart transplantation from May 1990 to November 1991. Both groups did not differ significantly with respect to age, sex, indication for heart transplantation, and preoperative renal function. With urodilatin treatment, renal function was significantly improved with lower peak plasma creatinine (1.83 +/- 0.1 versus 2.47 +/- 0.19 mg/dl; p = 0.003), lower peak serum urea (118 +/- 7 versus 178.3 +/- 10.3 mg/dl; p = 0.0036) and absence of hemodialysis (0% versus 10%; p = 0.026). Additionally, adequate diuresis was maintained although furosemide was reduced by more than 50% (p = 0.005) on each day of urodilatin treatment. Mean central venous pressure was significantly lower (-2 mm Hg; p = 0.02) during application of urodilatin, despite reduction of vasodilator therapy with nitroglycerin by about 50% (p = 0.02). Because of the significantly improved renal function and beneficial hemodynamic effects, the recommendation is therefore to introduce urodilatin in the postoperative treatment protocol after heart transplantation.

Adult↗