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Studying the effect of aminophylline use on the ability to wean from mechanical ventilation in intubated patients with brain injuries.

Evaluating the Effect of Aminophylline on Wining Ability from Mechanical Ventilation in Intubated Patient with Traumatic Brain Injury.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170608034390N16
Enrollment
90
Registered
2024-12-30
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Patients with Traumatic brain injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: Aminophylline produced by Sinadaroo Company, Tehran, Iran. Aminophylline administrated with a loading dose of 5 mg/kg (maximum 500 mg) and a maintenance dose based

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with Traumatic Brain Injury undergoing mechanical ventilation for at least 48 hours.

Exclusion criteria

Exclusion criteria: Patients with a history of allergy to theophylline, caffeine or aminophylline Patients with a history of severe asthma or chronic obstructive pulmonary disease Patients treated with theophylline, caffeine or other methylxanthines Users of drugs that increase or decrease theophylline/aminophylline levels (allopurinol (over 600 mg per day), cimetidine, ciprofloxacin, erythromycin, fluvoxamine, pentoxifylline, propranolol, verapamil, carbamazepine, fosphenytoin, phenobarbital, phenytoin, rifampicin and ritanavir)

Design outcomes

Primary

MeasureTime frame
The need for re-intubation in patients. Timepoint: Patient follow-up points will be during extubation and 7 days after. Method of measurement: Rapid shallow index.

Secondary

MeasureTime frame
Intubation failure rate. Timepoint: Up to 7 days after extubation of the patient. Method of measurement: Need for re-intubation within a week after extubation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Esmaily

Shahid Beheshti University of Medical Sciences

esmaily_hadi@sbmu.ac.ir+98 21 8887 3704

Outcome results

None listed

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