NCT03717168

Effects of Growth Hormone on Difficult Ventilator Weaning Patients

Role of Recombinant Human Growth Hormone rHGH in Weaning of Prolonged Ventilation After Major Abdominal Cancer Surgeries.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Major abdominal surgeries may be followed by postoperative pulmonary complications (PPCs). These complications are common and can cause significant morbidity and mortality. Major operations are followed by acute respiratory insufficiency (RI) in 3%-27.4%, which causes prolonged hospital stay, high patient costs, high mortality rate and lower survival rates. The most crucial pulmonary postoperative complication is the prolonged mechanical ventilation and difficult weaning.The rHGH is a synthetic metabolic hormone which improves synthesis of protein, corrects hypoalbumenia, reverses negative nitrogen balance, improves patient nutrition, improves wound healing and promotes recovery of respiratory muscle function. When used for weaning from mechanical ventilation, rHGH reducess the duration of mechanical ventilation time, ICU admission period, incidence of VAP \& ICU mortality.

Detailed description

Major abdominal surgeries may be followed by postoperative pulmonary complications (PPCs). These complications are common and can cause significant morbidity and mortality. Major operations are followed by acute respiratory insufficiency (RI) in 3%-27.4%, which causes prolonged hospital stay, high patient costs, high mortality rate and lower survival rates. The most crucial pulmonary postoperative complication is the prolonged mechanical ventilation and difficult weaning.The rHGH is a synthetic metabolic hormone which improves synthesis of protein, corrects hypoalbumenia, reverses negative nitrogen balance, improves patient nutrition, improves wound healing and promotes recovery of respiratory muscle function. When used for weaning from mechanical ventilation, rHGH reducess the duration of mechanical ventilation time, ICU admission period, incidence of VAP \& ICU mortality. Felbinger et al reported a case of prolonged ventilation with failure of weaning after 42 days; the patient received subcutaneous rHGH (0.3 IU/kg/day) for 20 days in addition to intensive care standard management. They reported improvement of protein metabolism in addition to improvement of respiratory muscle strength, the patient was weaned successfully on the 75th postoperative day.this study assumes a hypothesis that rHGH would help weaning from mechanically ventilated tracheostomized patients.

Conditions

• Mechanical Ventilation Complication

Interventions

Type	Name	Description
DRUG	Recombinant human growth hormone	All the patients received subcutaneous rHGH (0.3 IU/kg/ twice daily) for 10 days in addition to intensive care standard management.
OTHER	Control	All patients will not receive growth hormone.

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-08-30
• Completion: 2018-08-30
• First posted: 2018-10-24
• Last updated: 2019-08-21

Locations

1 site across 1 country: Egypt