Encephalopathy Clinical Trial
— CaffeinICUOfficial title:
CaffeinICU Study - A Randomized Controlled Multi-centre Pilot Study, on the Efficacy of Oral Caffeine, in Reducing the Duration of Mechanical Ventilation in Critically Ill Adult Patients
Background: Depressed Glasgow Coma Scale (GCS) is common among critically ill patient s in the intensive care unit (ICU). It is one of the main reasons that hampers liberation from mechanical ventilation among ICU patients. Caffeine is commonly used in neonates for the treatment of apnea of prematurity. However, its efficacy has not been established in adult population. Objective: To find out the efficacy of oral caffeine in shortening duration of mechanical ventilation among adult patients. Hypothesis: Oral caffeine is effective as a central nervous system stimulant among adult patients with depressed GCS. Study design: Multi-center, randomised, double blind, placebo controlled clinical trial Population: Adult patients (≥ 21 years old) with GCS ≤ 8 from any causes (excluding surgically reversible causes) requiring continuation of mechanical ventilation, whom acute medical issues are stable or has resolved but not suitable for extubation solely due to depressed GCS, not planned for any surgical procedures within 24 hours and not on sedative agents for at least 24 hours, will be included in this study. For patients with primary Central Nervous System (CN lesions, neurologist or neurosurgeon approval will be obtained prior to recruitment. The exclusion criteria include known allergy or adverse reactions from caffeine, pregnant women, breast-feeding women, uncontrolled cardiac arrhythmias, uncontrolled hypertension, hyperactive delirium, patients with chronic kidney disease (CKD, any stage) who received midazolam or morphine infusion, patients who received barbiturate coma, patients who are on theophylline, aminophylline or psychotropic agents at the point of screening for recruitment, patients with feed intolerant, short bowel syndrome and active seizures. Intervention: Oral caffeine citrate 5mg/kg/dose twice a day (8am, 2pm) vs placebo Outcomes: Primary - Duration of mechanical ventilation Secondary - ICU mortality, 30-days mortality, ICU length of stay, blood pressure, heart rate, incidence of arrhythmia, GCS, incidence of re-intubation and need for tracheostomy
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 130 Years |
Eligibility | Inclusion Criteria: 1. Adult patients (= 21 years old), 2. Patients with encephalopathy (GCS = 8) limiting extubation, where encephalopathy is deemed by clinician to be unresponsive to treatment or not eligible for treatment to reverse the encephalopathy (eg. transplantation) or if no treatment exists, and 3. Patients who are not planned for any surgical procedures within 24 hours 4. Patients who are not on sedative agents for at least 24 hours (exception for low dose fentanyl of up to 30mcg/h and dexmedetomidine of up to 0.5mcg/kg/h for analgesia/sedation/tube tolerance) - For patients with primary CNS lesions, neurologist or neurosurgeon approval will be obtained prior to recruitment. Exclusion Criteria: 1. Known allergy or adverse reactions from caffeine, 2. Pregnant women, 3. Breast-feeding women, 4. Patients with uncontrolled cardiac arrhythmias, 5. Patients with uncontrolled hypertension, 6. Patients with hyperactive delirium, 7. Patients with chronic kidney disease (CKD, any stage) who received midazolam or morphine infusion during their ICU stay, 8. Patients who received barbiturate coma, 9. Patients who are on theophylline, aminophylline or psychotropic agents at the point of screening for recruitment, 10. Patients with feed intolerant, short bowel syndrome, or 11. Patients with active seizures |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital | Sengkang General Hospital |
Singapore,
Bright M, Raman V, Laupland KB. Use of therapeutic caffeine in acute care postoperative and critical care settings: a scoping review. BMC Anesthesiol. 2021 Mar 31;21(1):100. doi: 10.1186/s12871-021-01320-x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of mechanical ventilation | Duration of mechanical ventilation in days | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | ICU mortality | Mortality in the ICU (yes or no) | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | 30-days mortality | Mortality within 30 days (yes or no) | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | ICU length of stay | Length of ICU stay in days | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | Blood pressure | Blood pressure in mmHg | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | Heart rate | Heart rate in beats per minute | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | Incidence of arrhythmia | Incidence of arrhythmia reported (yes or no) | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | GCS | Glasgow coma scale | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | Incidence of re-intubation | Need for re-intubation following an extubation (yes or no) | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | Incidence of terminal extubation | Terminal extubation in the ICU (yes or no) | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier | |
Secondary | Need for tracheostomy | Need for tracheostomy (yes or no) | From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier |
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