Evaluation of nebulized heparin efficacy in acute respiratory distress syndrome

Evaluation of nebulized heparin efficacy in pediatric patients with acute respiratory distress syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230724058907N1

Enrollment

Registered

2023-12-11

Start date

2023-12-22

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome. Acute respiratory distress syndrome

Interventions

Intervention 1: Intervention group with nebulized heparin 5000 unit per 1 milliliter Sina darou (preservative free) with dose100 Unit per kilogram of body weight every 12hours for 7 days. Intervention

Eligibility

Sex/Gender

All

Age

1 Months to 18 Years

Inclusion criteria

Inclusion criteria: Children older than one month to 18 years old The underlying disease of acute respiratory distress syndrome Patients under mechanical ventilation for more than 48 hours with Pao2/Fio2)

Exclusion criteria

Exclusion criteria: History of allergy to heparin Bleeding history in the last 3 months History of any bleeding and coagulation disorders History of cerebral hemorrhage in the last year Uncontrolled active bleeding Simultaneous use of antiplatelet, anticoagulant and thrombolytic drugs Unwillingness to participate in the study

Design outcomes

Primary

Measure	Time frame
Severity of acute respiratory distress syndrome. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Pediatric acute respiratory distress syndrome criteria.	—

Secondary

Measure	Time frame
Oxygen saturation with palse oximetry to fraction of inspired oxygen ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Pulse oximetry and mechanical ventilator.;Arterial oxygen pressure by arterial blood gas to fraction of inspired oxygen ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Blood sample and mechanical ventilator.;Oxigen saturation index ( fraction of inspired oxygen mean airway pressure100 ) to oxygen saturation by palse oximetry ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Pulse oximetry and mechanical ventilator.;Oxygenation index (fraction of inspired oxygen mean airway pressure100) to oxygen saturation by arterial blood gas ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Blood sample and mechanical ventilator.;Number of days required mechanical ventilation. Timepoint: Time to enter the study to discharge. Method of measurement: Patient file.;Length of stay in Intensive Care Unit. Timepoint: Time to enter the study to discharge. Method of measurement: Patient file.;Adverse effect. Timepoint: Full time of study. Method of measurement: Patient file and tests.	—

Measure

Time frame

Oxygen saturation with palse oximetry to fraction of inspired oxygen ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Pulse oximetry and mechanical ventilator.;Arterial oxygen pressure by arterial blood gas to fraction of inspired oxygen ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Blood sample and mechanical ventilator.;Oxigen saturation index ( fraction of inspired oxygen *mean airway pressure*100 ) to oxygen saturation by palse oximetry ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Pulse oximetry and mechanical ventilator.;Oxygenation index (fraction of inspired oxygen *mean airway pressure*100) to oxygen saturation by arterial blood gas ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Blood sample and mechanical ventilator.;Number of days required mechanical ventilation. Timepoint: Time to enter the study to discharge. Method of measurement: Patient file.;Length of stay in Intensive Care Unit. Timepoint: Time to enter the study to discharge. Method of measurement: Patient file.;Adverse effect. Timepoint: Full time of study. Method of measurement: Patient file and tests.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzaneh Hematian

Ahvaz University of Medical Sciences

minagarfatima@gmail.com+98 61 3444 9003

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026