BACKGROUND: Xigris (recombinant human activated protein C) has recently been introduced as a treatment for severe sepsis following a large multicentre trial (the PROWESS trial). MATERIAL AND METHODS: Critical review of the original paper, follow-up studies and commentaries, and subgroup analyses from the US Food and Drug Administration. RESULTS: Changes in trial design after the start of the trial as well as inconsistent results in two phases of the trial make interpretation difficult. The overall trial results indicate a small benefit from treatment with activated protein C. However, subgroup analysis reveals that several groups of patients appeared to have little benefit. The drug may have severe and potentially lethal side effects in some patients. INTERPRETATION: Although activated protein C may have beneficial effects in some patients with severe sepsis, the effect on different subgroups of patients remains to be clarified. We conclude that there is at present insufficient documentation for a recommendation of activated protein C in patients with severe sepsis.

Animals↗

PubMed2003

Medical end-of-life decisions in Norway.

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Attitude of Health Personnel↗

PubMed2002

[The dying patient's preferences when end-of-life decisions are made].

BACKGROUND, MATERIAL AND METHODS: In this presentation we discuss end-of-life decisions on the basis of the history of a young patient with motor neuron disease and pneumonia. RESULTS: The patient wanted treatment for an acute pneumonia. Weaning from the respirator turned out to be difficult and the patient's condition was complicated by pneumothorax. He refused further treatment and managed to disconnect the respirator. He even tried self-extubation, but did not succeed, as his muscle strength was impaired. After two days the pneumothorax had spontaneously resorbed and the patient was awake. He refused further treatment and demanded that all therapy be stopped. A meeting was held of the ad hoc established local clinical ethical committee. The patient was conscious, mentally alert and well informed. The respirator was stopped and the orotracheal tube removed. The physician and nurse stayed bedside, ready to intervene if the patient wanted the ventilator treatment re-established, or to give pharmacological treatment for pain, respiratory distress, or anxiety. The patient was calm for five minutes, after that he started to feel respiratory distress. After a short while consciousness was lost, and he died after 30 minutes. INTERPRETATION: Ethical challenges are discussed. The story illustrates the importance of good communication between patient and doctor to facilitate the patient's autonomy.

Adult↗