Status:
SUSPENDED
CaffeinICU Study - A Study on Oral Caffeine in ICU Patients With Coma
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Sengkang General Hospital
Conditions:
Depressed GCS
Eligibility:
All Genders
21-130 years
Phase:
PHASE2
Brief Summary
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 ventila...
Detailed Description
Depressed Glasgow Coma Scale (GCS) is common among critically ill patients in the intensive care unit (ICU). It is one of the main reasons that hampers liberation from mechanical ventilation among ICU...
Eligibility Criteria
Inclusion
- Adult patients (≥ 21 years old),
- 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
- Patients who are not planned for any surgical procedures within 24 hours
- 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
- Known allergy or adverse reactions from caffeine,
- Pregnant women,
- Breast-feeding women,
- Patients with uncontrolled cardiac arrhythmias,
- Patients with uncontrolled hypertension,
- Patients with hyperactive delirium,
- Patients with chronic kidney disease (CKD, any stage) who received midazolam or morphine infusion during their ICU stay,
- 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, or
- Patients with active seizures
Key Trial Info
Start Date :
November 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05232734
Start Date
November 24 2022
End Date
December 31 2025
Last Update
June 27 2024
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608