Effects of Growth Hormone on Difficult Ventilator Weaning Patients
NCT ID: NCT03717168
Last Updated: 2019-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2018-03-01
2018-08-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Recombinant human growth hormone
Patients who received growth hormone immediately after tracheostomy.
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.
Control
Patients who did not receive growth hormone and followed the conventional weaning trials
Control
All patients will not receive growth hormone.
Interventions
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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.
Control
All patients will not receive growth hormone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients requiring prolonged postoperative ventilation.
* Patients with multiple failed trials of mechanical ventilation weaning.
* ASA I and II patients.
Exclusion Criteria
* Septic or septic shock patients on inotropic supports.
* Fully alert and Conscious patients.
* ASA 3 and 4.
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute, Egypt
OTHER
Responsible Party
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Ehab Hanafy Shaker
Principal investigator
Principal Investigators
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Ehab H Shaker, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute- Cairo University
Locations
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Department of Anesthesia and Pain medicine.National Cancer Institute
Cairo, , Egypt
Countries
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Related Links
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the use of growth hormone for postoperative respiratory failure
Other Identifiers
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Ehab- Mahmoud growth hormone
Identifier Type: -
Identifier Source: org_study_id
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