Streptokinase Versus Unfractionated Heparin Nebulization in Severe ARDS

Summary

Background: Intra-alveolar clotting and alveolar collapse in ARDS is due to alveolar capillaries epithelial and leakage. Subsequently, collapse induces hypoxemia that is resistant to recruitment (RM). Heparin and Streptokinase may prevent or dissolve intra-alveolar fibrin clot respectively helping alveolar re-expansion. We examined and compared the effect of nebulizing Heparin versus Streptokinase on reversing this pathology.

Methods: Sixty severe ARDS (PaO2/FiO2\<100) patients and failure of RM, prone position (PP) and neuromuscular block (NMB) were partially randomised into Group (I): (n=20) received nebulized Heparin 10000 IU/4h. Group (II): (n=20) received nebulized Streptokinase 250,000 IU/4h. Group (III): (n=20) received conservative management. Randomization to either Heparin or Streptokinase groups was applied to patients whom guardian accepted participation, while those who declined participation were followed-up as a control. The primary outcome was the change in PaO2/FiO2; the secondary outcomes included the change in compliance, plateau pressure, ventilation-off days, coagulation and ICU mortality.

Conditions

• Acute Respiratory Distress Syndrome
• Severe Acute Respiratory Syndrome

Interventions

DRUG

Unfractionated heparin

Heparin or Streptokinase were nebulized by Aeroneb Pro@ Lab mesh nebulizer (Aerogen Limited, Galway, Ireland) which is incorporated within GE Healthcare's Engström Carestation ventilator (General Electric Company, Finland). Aeroneb nebulizer is a palladium vibrating mesh nebulizer. The central aperture plate of the nebulizer is 5mm in diameter and is perforated with 1000 precision formed holes, that vibrate at 128,000 times per second, to produce the particles with size 1-5 micron in diameter with average MMAD (Mean Mass Aerodynamic Diameter) is 2.1 microns. The nebulized medication (either streptokinase 250,000 IU or heparin 10.000 IU) was prepared in 3 ml volume of distilled water and nebulized for a period of 15 minutes every 4 hours.

DRUG

Streptokinase

Heparin or Streptokinase were nebulized by Aeroneb Pro@ Lab mesh nebulizer (Aerogen Limited, Galway, Ireland) which is incorporated within GE Healthcare's Engström Carestation ventilator (General Electric Company, Finland). Aeroneb nebulizer is a palladium vibrating mesh nebulizer. The central aperture plate of the nebulizer is 5mm in diameter and is perforated with 1000 precision formed holes, that vibrate at 128,000 times per second, to produce the particles with size 1-5 micron in diameter with average MMAD (Mean Mass Aerodynamic Diameter) is 2.1 microns. The nebulized medication (either streptokinase 250,000 IU or heparin 10.000 IU) was prepared in 3 ml volume of distilled water and nebulized for a period of 15 minutes every 4 hours.

Sponsors & Collaborators

• Beni-Suef University

  lead OTHER

Principal Investigators

• Hatem Hatem Elmoutaz Mahmoud, MD · Beni-Suef University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-18

Primary Completion

2018-01-30

Completion

2018-01-30