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Effects of Growth Hormone on Difficult Ventilator Weaning Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717168
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ehab Hanafy Shaker, 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.


Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Drug: Recombinant human growth hormone Other: Control Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of Recombinant Human Growth Hormone rHGH in Weaning of Prolonged Ventilation After Major Abdominal Cancer Surgeries.
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Active Comparator: Recombinant human growth hormone
Patients who received growth hormone immediately after tracheostomy.
Drug: 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.
Other Name: drug group

Active Comparator: Control
Patients who did not receive growth hormone and followed the conventional weaning trials
Other: Control
All patients will not receive growth hormone.
Other Name: control group




Primary Outcome Measures :
  1. The effect of rHGH on the mechanical ventilation time in patients underwent abdominal cancer surgery and needed postoperative mechanical ventilation for a long period [ Time Frame: up to 6 weeks. ]
    The total mechanical ventilation days.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717168


Locations
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Egypt
Department of Anesthesia and Pain medicine.National Cancer Institute
Cairo, Egypt, 11796
Sponsors and Collaborators
National Cancer Institute, Egypt
Investigators
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Principal Investigator: Ehab H Shaker, MD National Cancer Institute- Cairo University

Additional Information:
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Responsible Party: Ehab Hanafy Shaker, Principal investigator, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier: NCT03717168    
Other Study ID Numbers: Ehab- Mahmoud growth hormone
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: after finishing the study and submitting to a highly impact journal will share the data and results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ehab Hanafy Shaker, National Cancer Institute, Egypt:
recombinant growth hormone
Difficult ventilator weaning
postoperative complications
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs