Effects of Growth Hormone on Difficult Ventilator Weaning Patients

National Cancer Institute, Egypt

Status and phase: Completed; Phase 2

Conditions: Mechanical Ventilation Complication

Treatments: Other: Control; Drug: Recombinant human growth hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT03717168

Ehab- Mahmoud growth hormone

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing major abdominal cancer surgeries.
• Patients requiring prolonged postoperative ventilation.
• Patients with multiple failed trials of mechanical ventilation weaning.
• ASA I and II patients.

Exclusion criteria

• History of chronic cardiac,renal or respiratory illness.
• Septic or septic shock patients on inotropic supports.
• Fully alert and Conscious patients.
• ASA 3 and 4.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Recombinant human growth hormone

Active Comparator group

Description:

Patients who received growth hormone immediately after tracheostomy.

Treatment:

Drug: Recombinant human growth hormone

Control

Active Comparator group

Description:

Patients who did not receive growth hormone and followed the conventional weaning trials

Treatment:

Other: Control