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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717168
Enrollment
60
Registered
2018-10-24
Start date
2018-03-01
Completion date
2018-08-30
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication

Keywords

recombinant growth hormone, Difficult ventilator weaning, postoperative complications

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.

Interventions

DRUGRecombinant 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.

OTHERControl

All patients will not receive growth hormone.

Sponsors

National Cancer Institute, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026