Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-01 @ 6:13 PM
Study NCT ID:
NCT03717168
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2018-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Growth Hormone on Difficult Ventilator Weaning Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': 'The total mechanical ventilation days.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recombinant growth hormone', 'Difficult ventilator weaning', 'postoperative complications'], 'conditions': ['Mechanical Ventilation Complication']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/8678203', 'label': 'the use of growth hormone for postoperative respiratory failure'}]}, 'descriptionModule': {'briefSummary': 'Major abdominal surgeries may be followed by postoperative pulmonary complications (PPCs). These complications are common and can cause significant morbidity and mortality.\n\nMajor 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.', 'detailedDescription': 'Major abdominal surgeries may be followed by postoperative pulmonary complications (PPCs). These complications are common and can cause significant morbidity and mortality.\n\nMajor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing major abdominal cancer surgeries.\n* Patients requiring prolonged postoperative ventilation.\n* Patients with multiple failed trials of mechanical ventilation weaning.\n* ASA I and II patients.\n\nExclusion Criteria:\n\n* History of chronic cardiac,renal or respiratory illness.\n* Septic or septic shock patients on inotropic supports.\n* Fully alert and Conscious patients.\n* ASA 3 and 4.'}, 'identificationModule': {'nctId': 'NCT03717168', 'briefTitle': 'Effects of Growth Hormone on Difficult Ventilator Weaning Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Role of Recombinant Human Growth Hormone rHGH in Weaning of Prolonged Ventilation After Major Abdominal Cancer Surgeries.', 'orgStudyIdInfo': {'id': 'Ehab- Mahmoud growth hormone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Recombinant human growth hormone', 'description': 'Patients who received growth hormone immediately after tracheostomy.', 'interventionNames': ['Drug: Recombinant human growth hormone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients who did not receive growth hormone and followed the conventional weaning trials', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Recombinant human growth hormone', 'type': 'DRUG', 'otherNames': ['drug group'], 'description': 'All the patients received subcutaneous rHGH (0.3 IU/kg/ twice daily) for 10 days in addition to intensive care standard management.', 'armGroupLabels': ['Recombinant human growth hormone']}, {'name': 'Control', 'type': 'OTHER', 'otherNames': ['control group'], 'description': 'All patients will not receive growth hormone.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Department of Anesthesia and Pain medicine.National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ehab H Shaker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute- Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'after finishing the study and submitting to a highly impact journal will share the data and results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ehab Hanafy Shaker', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}