OBJECTIVE: To examine the effect of recombinant human growth hormone (rhGH) on the catabolic state following major gastrointestinal surgery. DESIGN: The study was designed as a prospective controlled randomized clinical trial. SETTING: Intensive care unit and the surgical ward of the Department of Surgery, Städtische Kliniken Dortmund, FRG. PATIENTS: 39 patients were studied postoperatively following gastrectomy or resection of the rectum. The patients were 40-75 years old. INTERVENTION: 0.075 (n = 11), 0.15 (n = 9) or 0.30 IU rhGH/kg/day (n = 9) or placebo (n = 10) were given subcutaneously at 8:00 a.m. during 5 postoperative days. Resting energy expenditure (REE) on the 1st postoperative day was 2,042 +/- 82 kcal/24 h (REE/BEE 1.44 +/- 0.04). Isocaloric, isonitrogenous total parenteral nutrition provided the energy requirements (4 g carbohydrates/kg, 0.9 g fat/kg, 1.25 g amino acids/kg). RESULTS: After 5 days of treatment, cumulated nitrogen balance (CNB) was improved dose-relatedly. In controls, net nitrogen losses (-20.47 +/- 3.86 g) were significantly higher than after 0.15 (-12.14 +/- 3.5 g) and 0.30 IU rhGH/kg (-10.0 +/- 2.61 g). 0.075 IU rhGH/kg showed no significant effect on CNB (-18.07 +/- 5.73 g). The modulation of protein metabolism by GH may be mediated by insulin-like growth factor-I (IGF-I). Postoperatively serum (S)-IGF-I was decreased in all groups. rhGH caused a significant dose-related increase in S-IGF-I levels on day 6, whereas in controls it remained unchanged during the study period. Besides significant elevations in serum glucose in some cases of both larger dosage groups no side effects were detected. CONCLUSIONS: The protein-sparing effect of rhGH after major gastrointestinal surgery is dose related but not linear. A threshold value for a significant improvement in the CNB seems to be at least at 0.15 IU rhGH/kg/day.
RCT Entities:
OBJECTIVE: To examine the effect of recombinant humangrowth hormone (rhGH) on the catabolic state following major gastrointestinal surgery. DESIGN: The study was designed as a prospective controlled randomized clinical trial. SETTING: Intensive care unit and the surgical ward of the Department of Surgery, Städtische Kliniken Dortmund, FRG. PATIENTS: 39 patients were studied postoperatively following gastrectomy or resection of the rectum. The patients were 40-75 years old. INTERVENTION: 0.075 (n = 11), 0.15 (n = 9) or 0.30 IU rhGH/kg/day (n = 9) or placebo (n = 10) were given subcutaneously at 8:00 a.m. during 5 postoperative days. Resting energy expenditure (REE) on the 1st postoperative day was 2,042 +/- 82 kcal/24 h (REE/BEE 1.44 +/- 0.04). Isocaloric, isonitrogenous total parenteral nutrition provided the energy requirements (4 g carbohydrates/kg, 0.9 g fat/kg, 1.25 g amino acids/kg). RESULTS: After 5 days of treatment, cumulated nitrogen balance (CNB) was improved dose-relatedly. In controls, net nitrogen losses (-20.47 +/- 3.86 g) were significantly higher than after 0.15 (-12.14 +/- 3.5 g) and 0.30 IU rhGH/kg (-10.0 +/- 2.61 g). 0.075 IU rhGH/kg showed no significant effect on CNB (-18.07 +/- 5.73 g). The modulation of protein metabolism by GH may be mediated by insulin-like growth factor-I (IGF-I). Postoperatively serum (S)-IGF-I was decreased in all groups. rhGH caused a significant dose-related increase in S-IGF-I levels on day 6, whereas in controls it remained unchanged during the study period. Besides significant elevations in serum glucose in some cases of both larger dosage groups no side effects were detected. CONCLUSIONS: The protein-sparing effect of rhGH after major gastrointestinal surgery is dose related but not linear. A threshold value for a significant improvement in the CNB seems to be at least at 0.15 IU rhGH/kg/day.