CaffeinICU Study - A Pilot Study on the Efficacy of Oral Caffeine in Reducing the Duration of Mechanical Ventilation

• Status: Not yet recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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 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 CNS 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 BD (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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Collaborator: Sengkang General Hospital
• Treatments: Caffeine; Caffeine citrate

Criteria

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