Effects of Growth Hormone on Difficult Ventilator Weaning Patients

NCT03717168 | Completed Phase 2

• 1 other identifier: Ehab- Mahmoud growth hormone
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication

Keywords

recombinant growth hormone; Difficult ventilator weaning; postoperative complications

Outcome Measures

Primary Outcomes (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

  The total mechanical ventilation days.

  up to 6 weeks.

Study Arms (2)

Recombinant human growth hormone

ACTIVE COMPARATOR

Patients who received growth hormone immediately after tracheostomy.

Drug: Recombinant human growth hormone

Control

ACTIVE COMPARATOR

Patients who did not receive growth hormone and followed the conventional weaning trials

Other: Control

Interventions

Recombinant human growth hormone DRUG

All the patients received subcutaneous rHGH (0.3 IU/kg/ twice daily) for 10 days in addition to intensive care standard management.

Also known as: drug group

Recombinant human growth hormone

Control OTHER

All patients will not receive growth hormone.

Also known as: control group

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

Location

Related Links

• the use of growth hormone for postoperative respiratory failure

MeSH Terms

Conditions

Postoperative Complications

Interventions

Growth Hormone; Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ehab H Shaker, MD

  National Cancer Institute- Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: March 1, 2018
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)