Role of recombinant human growth hormone in weaning of prolonged ventilation after major abdominal cancer surgeries; open-label, placebo-controlled, randomized trial

Abstract

Objective:  The use of recombinant human growth hormone (rhGH) in difficult to wean patients with prolonged ventilation periods may increase the likelihood of weaning and thus reduce the mechanical ventilation time. This placebo-controlled randomized study aimed to assess the efficacy of rhGH on the weaning of prolonged mechanical ventilation.

Study Design: The study was conducted in the National Cancer Institute, Cairo, Egypt, from March 2018 to August 2018. Enrolled patients (60) were randomized to the GH group and the control group, 30 in each group. Before randomization, the same management was offered to both groups. After randomization, in the GH group, patients received 4 IU rhGH IM, twice per day for ten days. In the control group, patients received placebo injections (saline) at the same intervals and conditions with the continuation of the regular ICU management given to both groups. The primary outcome measurement was the proportion of patients weaned in both groups.

Results: There was no statistically significant difference (P > 0.05) between the two groups regarding their baseline data in terms of age, BMI, and gender. Ventilation days were significantly lower in the GH group than in the control group; 33.20 ± 16.57 vs. 48.73 ± 10.66 days (P < 0.001). The number of failed-to- wean patients was significantly lower in the GH group than the control group [10 (33.33%) vs. 22 (73.33%); (P = 0.002)]. The odds ratio (OR) was 0.18 (95% CI: 0.06-0.55), the Absolute Risk Reduction (ARR) was 0.4 (95% CI: 0.17-0.63) and the Number Needed to Treat (NNT) was 2.5 (95% CI: 1.58-5.93). In addition, the study showed no significant differences between the GH group and the control group concerning the blood pressure, blood sugar. During the study period, there was no statistically significant difference between groups as regards the incidence of ventilator-associated pneumonia (VAP) or the number of deaths.

Conclusion: The use of rhGH in cases difficult-to-wean patient with prolonged ventilation period increases the likelihood of weaning and reduces the mechanical ventilation time.

Abbreviations: rhGH - Recombinant human growth hormone BMI – Body mass index; NNT - Number Needed to Treat; ARR - Absolute Risk Reduction; VAP - ventilator-associated pneumonia; PPC - Postoperative pulmonary complication; RSBI - rapid shallow breathing index; HIPEC - Hyperthermic intraperitoneal chemotherapy 

Clinical Trial Registration: NCT03717168: https://clinicaltrials.gov/ct2/show/NCT03717168

Key words: Growth hormone; rhGH; prolonged mechanical ventilation; respiratory failure; VAP

Citation: Skaker EH, Kamel MA. Role of recombinant human growth hormone in weaning of prolonged ventilation after major abdominal cancer surgeries; open-label, placebo-controlled, randomized trial. Anaesth. pain intensive care 2022;26(2):175–181; DOI: 10.35975/apic.v26i2.1833

Received: June 23, 2021; Reviewed: January 29, 2022; Accepted: January 29, 2022