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IRCT20250430065541N1 IRCT 2026-02-27 Alborz University of Medical Sciences Effect of caffeine in COPD Evaluating the effectiveness of caffeine on blood gases and short-term hospital outcomes in patients with acute COPD exacerbation requiring NIV in patients referred to Bahonar Emergency Department. 2026-04-04 anticipated 70 Recruiting https://irct.ir/trial/83259 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized, double-blind, placebo-controlled, parallel-group clinical trial. Randomization will be performed using block randomization method with block sizes of 4 and 6, using a computer-generated random number sequence. The study includes 140 patients (70 in each group) with acute exacerbation of COPD requiring non-invasive ventilation (NIV), Randomization description: Patients eligible for the study will be determined and 70 of them will be selected as available. Based on a random number table, they will be randomly divided into two intervention and control groups (each group includes 35 people) using a random block permutation method with blocks of size 4 (Random allocation), Blinding description: This study is designed as a double-blind study. - The caffeine and placebo capsules will be identical in shape, size, color, and packaging. - One person will be responsible for preparing, coding, and randomly distributing the containers based on the randomization list. - Participants, treating physicians, nurses, and researchers assessing clinical outcomes will be unaware of the contents of the capsules. 3 Chronic obstructive pulmonary disease. Intervention group: Caffeine tablets 200 mg orally every 12 hours for 5 days. Yes - There is a plan to make this available What will be shared: De-identified individual participant data (IPD) including demographic characteristics, arterial blood gas parameters (PH, PCO2, PO2), O2 saturation, Borg scale scores, intubation rates, length of hospital stay, ICU admission, and NIV duration. When: Immediately after publication of the main study results (expected by 2027). No end date. To whom: Researchers and clinicians affiliated with academic and scientific institutions who provide a methodologically sound proposal and sign a data access agreement. Conditions: For individual participant data meta-analysis, secondary analyses related to COPD exacerbation, respiratory physiology, or effects of caffeine on respiratory outcomes. Data should only be used for non-commercial scientific research purposes with proper citation of the original study. Where to obtain: Corresponding author: Dr. Somayeh Rezaian, Assistant Professor, Department of Internal Medicine, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran. Email: somaye.rezaian@gmail.com Alternative contact: Nasim Barjasteh (Principal researcher), Email: nasimbarjasteh@gmail.com, Tel: +98 914 560 0782 How to obtain: Interested researchers should submit a formal request via email to the corresponding author, including a brief research proposal and intended use of data. The proposal will be reviewed by the study team within 2-4 weeks. If approved, a data sharing agreement must be signed before data transfer. De-identified data will be provided electronically within 4-6 weeks after agreement finalization. Comments: Data will be shared in compliance with Alborz University of Medical Sciences ethics guidelines and Iranian national regulations for research data sharing. The study was approved by the ethics committee with reference ID: IR.ABZUMS.REC.1404.352 and registered in IRCT with tracking code: 890.
public Somayeh Rezaian
Taleghani Boulevard,Taleghani square
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3419 7000 somaye.rezaian@gmail.com Karaj University of Medical Sciences scientific Somayeh Rezaian
Taleghani Boulevard,Taleghani square
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3256 3318 somaye.rezaian@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) COPD patients who meet the criteria for COPD exacerbation (presence of any of the symptoms of worsening shortness of breath, increased sputum volume, increased sputum viscosity) COPD exacerbation patient who requires NIV during an attack Absence of contraindications to NIV placement (trauma or facial deformity, severe decreased level of consciousness, abundant pulmonary secretions, high risk of aspiration, cardiorespiratory arrest) Patient consents to participate in the study4 Age 40 to 85 years 40 years 85 years Both 1. Patient over 85 years of age Pregnancy History of caffeine sensitivity Patient unwillingness to participate in the study Decreased level of consciousness Facial or chest deformity Asthma Neuromuscular diseases and chest disorders Pneumothorax Persistent and frequent vomiting Intolerance to NIV for any reason Occurrence of caffeine side effects J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation Treatment - Drugs Intervention group: Caffeine tablets 200 mg orally every 12 hours for 5 days Change in arterial partial pressure of carbon dioxide (PaCO2) from baseline to day 5. Timepoint: Baseline (before intervention) and daily at 8:00 AM for 5 consecutive days. Method of measurement: Measured using a calibrated arterial blood gas analyzer from arterial blood samples. Alborz University of Medical Sciences Approved 2026-02-15 Ethics committee of Alborz University of Medical Sciences Alborz University of Medical Sciences(ABZUMS), Taleghani Boulevard, Taleghani square Karaj Alborz Iran (Islamic Republic of)