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Nebulized Heparin and Salbutamol in Mechanically Ventilated Patients With AECOPD

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ClinicalTrials.gov Identifier: NCT03333395
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Ibrahim Mamdouh Esmat, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Mechanically Ventilated Patients Drug: Nebulized heparin and salbutamol Drug: Nebulized salbutamol Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Nebulized Heparin and Salbutamol in Mechanically Ventilated Patients With Acute Exacerbation Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017


Arm Intervention/treatment
Active Comparator: HS Group (study group) Drug: Nebulized heparin and salbutamol
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.)

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




Primary Outcome Measures :
  1. The number of ventilator hours [ Time Frame: Maximum of 14 days from randomization. ]
    Number of hours during which the patient was mechanically ventilated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 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).

Exclusion Criteria:

  • 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.

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): NCT03333395


Locations
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Egypt
Internal Medicine ICU of Ain-Shams University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Dr.Ibrahim Mamdouh Esmat, Lecturer of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University
ClinicalTrials.gov Identifier: NCT03333395     History of Changes
Other Study ID Numbers: R 26 / 2017
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: November 2017

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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 Dr.Ibrahim Mamdouh Esmat, Ain Shams University:
Mechanical ventilation
Acute Exacerbation of chronic obstructive airway disease (AECOPD)
Nebulized heparin
C-Reactive Protein (CRP
Additional relevant MeSH terms:
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Heparin
Calcium heparin
Albuterol
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents