Twenty patients with generalized sepsis were studied prospectively to evaluate the effects of recombinant human growth hormone (rhGH) administration. Five patients had developed sepsis after major abdominal surgery, 15 patients after multiple trauma with head injury (HTI-ISS 38 +/- 2 and Glasgow Coma Scale 4 +/- 1). The urea production rate (UPR) could be significantly reduced by the intramuscular administration of 1.5 IU of rhGH/kg bodyweight (BW) per day (UPR day: 5, 62 +/- 6.7 gm/d vs. UPR day: 10, 42.6 +/- 5.9 gm/d). The catabolic index of Bistrian (BI) was significantly lower after rhGH therapy on day 10 compared to day 5. IGF-1 increased significantly after the administration of rhGH. The nitrogen balance, however, did not become positive, despite the administration of rhGH. The changes in sepsis were estimated by the scoring system according to Elebute and Stoner on days 3, 5, 7, 10, and 13. In those patients who were available for post-treatment evaluation the parameters had returned to baseline values after the withdrawal of rhGH. Results indicate that this therapy might ameliorate the nitrogen intake, but has no influence on the course of sepsis. Compared to previously published results in nonseptic patients, the somatomedin inhibitors as well as the split-products of the complement system and the metabolites of arachidonic acid may have been responsible for this weak effect of rhGH and IGF-1 in septicemia.