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CaffeinICU Study - A Study on Oral Caffeine in ICU Patients With Coma

NCT05232734 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-06-27

No results posted yet for this study

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 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

Conditions

  • Depressed GCS

Interventions

DRUG

Caffeine Citrate 20 MG/ML Oral Solution

Caffeine syrup will be prepared by pharmacy laboratory and kept refrigerated (2-8C), to be used within 1 month from the date of preparation by pharmacy laboratory.

Sponsors & Collaborators

  • Sengkang General Hospital

    collaborator OTHER

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Sharon GK Ong · A/Professor

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-24
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05232734 on ClinicalTrials.gov