Clinical trial NCT03717168: Effects of Growth Hormone on Difficult Ventilator Weaning Patients
Official title: Role of Recombinant Human Growth Hormone rHGH in Weaning of Prolonged Ventilation After Major Abdominal Cancer Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mechanical Ventilation Complication
Keywords: recombinant growth hormone
Difficult ventilator weaning
postoperative complications
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of rHGH on the mechanical ventilation time in patients underwent abdominal cancer surgery and needed postoperative mechanical ventilation for a long period
timeFrame: up to 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia and Pain medicine.National Cancer Institute
Study officials:
affiliation: National Cancer Institute- Cairo University
name: Ehab H Shaker, MD
role: PRINCIPAL_INVESTIGATOR
References: