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Effects of Growth Hormone on Difficult Ventilator Weaning Patients

Phase 2
Completed
Conditions
Mechanical Ventilation Complication
Interventions
Registration Number
NCT03717168
Lead Sponsor
National Cancer Institute, Egypt
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlControlPatients who did not receive growth hormone and followed the conventional weaning trials
Recombinant human growth hormoneRecombinant human growth hormonePatients who received growth hormone immediately after tracheostomy.
Primary Outcome Measures
NameTimeMethod
The effect of rHGH on the mechanical ventilation time in patients underwent abdominal cancer surgery and needed postoperative mechanical ventilation for a long periodup to 6 weeks.

The total mechanical ventilation days.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

🇪🇬

Cairo, Egypt

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