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

NCT05232734 | Suspended Phase 2 DMC

• 1 other identifier: 2021/2556
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Keywords

Caffeine; Depressed GCS; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• ICU mortality

  From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier

• 30-days mortality

  From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier

• ICU length of stay

  From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier

• Blood pressure

  From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier

• Heart rate

  From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier

Study Arms (1)

Oral caffeine group

EXPERIMENTAL

Patients in this arm will receive treatment with oral caffeine

Drug: Caffeine Citrate 20 MG/ML Oral Solution

Interventions

Caffeine Citrate 20 MG/ML Oral Solution DRUG

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.

Also known as: Caffeine

Oral caffeine group

Eligibility Criteria

• Age: 21 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sengkang General Hospital: collaborator
• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (1)

• 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.

  PMID: 33789583 BACKGROUND

MeSH Terms

Interventions

caffeine citrate; Solutions; Caffeine

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sharon GK Ong

  A/Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: The study drug is oral caffeine solution which will be prepared by pharmacy laboratory using caffeine powder into 20mg/mL caffeine solution. The solution will be packed in amber glass bottle ready for administration by nurses at bedside without further dilution.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center pilot observational single-arm clinical feasibility trial

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 10, 2022
• Study Start: November 24, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)