OBJECTIVE: To determine the effect of short-term recombinant human growth hormone (rhGH) administration on urea production rate (UPR), N balance and aminograms. DESIGN: Prospective, double-blind placebo-controlled study. SETTING:Intensive care unit of a University Hospital. PATIENTS: 20 adult patients after major abdominal surgery. INTERVENTIONS: Postoperative substitution of rhGH (Saizen, Serono, Aubonne, CH) in a dose of 0.15 IE/kg BW for 3 days. The serum levels of hGH, insulin-like growth factor-1 (IGF-1), ACTH and cortisol were measured as well as the amino acids in plasma. The degree of catabolism was calculated according to Woolfson's formula, which is based on the UPR, and by calculation of the cumulative N balance. RESULTS: With exception of proline, the plasma amino acids between the groups receiving active substance and total parenteral nutrition (TPN) and those receiving placebo and TPN did not differ significantly. Neither was there a significant difference between the groups for any other parameter measured. The UPR and IGF-1 levels showed only a tendency towards higher values as compared with the placebo group (UPR verum group, values in g/day: 1st measurement, 29.8 +/- 16.7; 2nd measurement, 28.3 +/- 17.7; 3rd measurement, 32.1 +/- 19.1; 4th measurement, 33.1 +/- 21.2. UPR placebo, values in g/day; 1st measurement, 32.6 +/- 23.9; 2nd measurement, 30.8 +/- 17.9; 3rd measurement 41.6 +/- 28.7; 4th measurement, 47.3 +/- 29.5. IGF-1 verum group, values in nmol/l; 1st measurement, 25.7 +/- 19.2; 2nd measurement, 44.8 +/- 23; 3rd measurement, 52.4 +/- 30; 4th measurement, 54.3 +/- 20. IGF-1 placebo, values in nmol/l; 1st measurement: 22.9 +/- 11.7; 2nd measurement, 37.0 +/- 19.4; 3rd measurement, 38.4 +/- 21.4; 4th measurement, 40.0 +/- 23.0). The ACTH-cortisol axis was only slightly depressed in the group receiving active substance. CONCLUSIONS: We conclude that short-term rhGH administration over 3 days is not capable of significantly reducing the UPR in postoperative patients, but we cannot exclude a significant difference between rhGH group and placebo after a longer administration period.
RCT Entities:
OBJECTIVE: To determine the effect of short-term recombinant humangrowth hormone (rhGH) administration on urea production rate (UPR), N balance and aminograms. DESIGN: Prospective, double-blind placebo-controlled study. SETTING: Intensive care unit of a University Hospital. PATIENTS: 20 adult patients after major abdominal surgery. INTERVENTIONS: Postoperative substitution of rhGH (Saizen, Serono, Aubonne, CH) in a dose of 0.15 IE/kg BW for 3 days. The serum levels of hGH, insulin-like growth factor-1 (IGF-1), ACTH and cortisol were measured as well as the amino acids in plasma. The degree of catabolism was calculated according to Woolfson's formula, which is based on the UPR, and by calculation of the cumulative N balance. RESULTS: With exception of proline, the plasma amino acids between the groups receiving active substance and total parenteral nutrition (TPN) and those receiving placebo and TPN did not differ significantly. Neither was there a significant difference between the groups for any other parameter measured. The UPR and IGF-1 levels showed only a tendency towards higher values as compared with the placebo group (UPR verum group, values in g/day: 1st measurement, 29.8 +/- 16.7; 2nd measurement, 28.3 +/- 17.7; 3rd measurement, 32.1 +/- 19.1; 4th measurement, 33.1 +/- 21.2. UPR placebo, values in g/day; 1st measurement, 32.6 +/- 23.9; 2nd measurement, 30.8 +/- 17.9; 3rd measurement 41.6 +/- 28.7; 4th measurement, 47.3 +/- 29.5. IGF-1 verum group, values in nmol/l; 1st measurement, 25.7 +/- 19.2; 2nd measurement, 44.8 +/- 23; 3rd measurement, 52.4 +/- 30; 4th measurement, 54.3 +/- 20. IGF-1 placebo, values in nmol/l; 1st measurement: 22.9 +/- 11.7; 2nd measurement, 37.0 +/- 19.4; 3rd measurement, 38.4 +/- 21.4; 4th measurement, 40.0 +/- 23.0). The ACTH-cortisol axis was only slightly depressed in the group receiving active substance. CONCLUSIONS: We conclude that short-term rhGH administration over 3 days is not capable of significantly reducing the UPR in postoperative patients, but we cannot exclude a significant difference between rhGH group and placebo after a longer administration period.