Nebulized Heparin and Salbutamol in Mechanically Ventilated Patients With AECOPD

NCT03333395 | Completed Phase 4

• 1 other identifier: R 26 / 2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised study was designed to assess the efficacy of nebulised heparin and salbutamol in improving lung function in mechanically ventilated patients with AECOPD.

Conditions

Mechanically Ventilated Patients

Keywords

Mechanical ventilation; Acute Exacerbation of chronic obstructive airway disease (AECOPD); Nebulized heparin; C-Reactive Protein (CRP

Outcome Measures

Primary Outcomes (1)

• The number of ventilator hours

  Number of hours during which the patient was mechanically ventilated.

  Maximum of 14 days from randomization.

Study Arms (2)

HS Group (study group)

ACTIVE COMPARATOR

Drug: Nebulized heparin and salbutamol

S Group (control group)

ACTIVE COMPARATOR

Drug: Nebulized salbutamol

Interventions

Nebulized heparin and salbutamol DRUG

HS Group medications (study group) (30 patients) which was prepared by adding Heparin 25000 IU in 5ml (5 ampoules of Heparin Sodium 5000 I.U/ML, Nile company for Pharmaceuticals and Chemical Industries-A.R.E.) to Salbutamol 5mg/2.5ml Nebulizer Solution (one Ventolin nebule containing a preservative-free solution of Salbutamol Sulphate BP 2.5mg, GlaxoSmithKline Inc.)

HS Group (study group)

Nebulized salbutamol DRUG

S Group medications (control group) (30 patients) which was prepared by adding Salbutamol 5mg/2.5ml Nebulizer Solution + Na cl 0.9% 5ml.

S Group (control group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> or = 18 years of age,
• body weight 70-110Kg,
• height 160-180 cm
• with clinically evident AECOPD and in need for mechanical ventilation confirmed by arterial blood gases (ABGs).

You may not qualify if:

• Excluded Patients from the study were those who were not enrolled within the first 24 hours of mechanical ventilation and those who were likely to be extubated within 24 hours. - History of ischemic heart disease,
• History of pulmonary bleeding within the previous 3 months,
• History of bleeding diathesis,
• Known to be allergic to heparin or
• History of thrombocytopenia after previous treatment with heparin.
• Female patients were excluded if they were pregnant or breast feeding.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Internal Medicine ICU of Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: February 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

EG (1)