Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-28 @ 10:33 PM
Study NCT ID:
NCT05232734
Status:
SUSPENDED
Last Update Posted:
2024-06-27
First Post:
2022-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CaffeinICU Study - A Study on Oral Caffeine in ICU Patients With Coma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C026189', 'term': 'caffeine citrate'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Multi-center pilot observational single-arm clinical feasibility trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Study amendment done in view of low recruitment numbers. Updated HSA approved study protocol awaiting IRB approval before study re-commences', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of mechanical ventilation', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Duration of mechanical ventilation in days'}], 'secondaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Mortality in the ICU (yes or no)'}, {'measure': '30-days mortality', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Mortality within 30 days (yes or no)'}, {'measure': 'ICU length of stay', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Length of ICU stay in days'}, {'measure': 'Blood pressure', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Blood pressure in mmHg'}, {'measure': 'Heart rate', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Heart rate in beats per minute'}, {'measure': 'Incidence of arrhythmia', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Incidence of arrhythmia reported (yes or no)'}, {'measure': 'GCS', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Glasgow coma scale'}, {'measure': 'Incidence of re-intubation', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Need for re-intubation following an extubation (yes or no)'}, {'measure': 'Incidence of terminal extubation', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Terminal extubation in the ICU (yes or no)'}, {'measure': 'Need for tracheostomy', 'timeFrame': 'From the start of study drug with follow up period of 30 days or until hospital discharge, whichever earlier', 'description': 'Need for tracheostomy (yes or no)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caffeine', 'Depressed GCS', 'Mechanical Ventilation'], 'conditions': ['Depressed GCS']}, 'referencesModule': {'references': [{'pmid': '33789583', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nDepressed 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.\n\nObjective:\n\nTo find out the efficacy of oral caffeine in shortening duration of mechanical ventilation among adult patients.\n\nHypothesis:\n\nOral caffeine is effective as a central nervous system stimulant among adult patients with depressed GCS.\n\nStudy design:\n\nMulti-center, randomised, double blind, placebo controlled clinical trial\n\nPopulation:\n\nAdult 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.\n\nIntervention:\n\nOral caffeine citrate 5mg/kg/dose twice a day (8am, 2pm) vs placebo\n\nOutcomes:\n\nPrimary - 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', 'detailedDescription': "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 patients. Current management of this disorder focuses mainly on supportive care and treatment of the underlying disease. Directed therapies targeting neurochemical and neurotransmitter pathways are not currently available and it represents an important area of research. Caffeine is commonly used in neonates for the treatment of apnea of prematurity. It is a CNS stimulant that stimulates central respiratory drive, increases medullary respiratory center sensitivity to carbon dioxide and improves diaphragmatic contractility. However, its efficacy has not been established in adult population.\n\nHypothesis:\n\n1. Oral caffeine is safe for use for adult ICU patients with depressed GCS at the selected dose.\n2. It is feasible to recruit the stipulated study population from SGH and SKH within the time frame of the study.\n\nObjective:\n\nThe primary objectives of the study are:\n\n1. To study the safety of oral caffeine among critically ill adult patients. Specifically, the investigators will observe for changes in the blood pressure and heart rate, as well as any incidence of arrthythmia among critically ill adult patients administered with oral caffeine\n2. To study the feasibility of the study. Specifically, the investigators will observe and examine factors and challenges (such as from the inclusion/exclusion criteria, caregiver's willingness to participate) that influence recruitment\n3. To estimate the duration of mechanical ventilation with the use of oral caffeine (dose: 5mg/kg/dose twice daily) in adult patients who are critically ill.\n\nThe secondary objectives are:\n\n(To describe the ICU mortality, 30-days mortality, ICU length of stay, GCS, incidence of re-intubation, incidence of terminal extubation and need for tracheostomy among critically ill adult patients administered with oral caffeine\n\nProposed Trial Design:\n\nThe investigators propose a pilot multi-center, single arm trial of 10 patients with depressed GCS, assigned to receive oral caffeine. 10 subjects from SGH and SKH who are on mechanical ventilation with depressed GCS will be recruited into this study. No randomisation or blinding will be carried out in this study.\n\nPlanned Trial Interventions:\n\nParticipants will receive oral caffeine through their feeding tube, 5mg/kg/dose twice daily. Oral caffeine solution (colorless and odorless) will be prepared by pharmacy laboratory and supplied in amber glass bottle. Potential drug-drug interaction with oral caffeine will be monitored throughout the study period:\n\n1. CYP1A2 enzyme inhibitors and inducers to be taken with caution/prohibited\n2. CYP1A2 substrates to be taken with caution/prohibited\n\nScreening Visits and Procedures:\n\nStudy subjects will be identified through referral by the attending ICU medical team or weekly patient screening. Potential subjects will be reviewed by one of the study team members for recruitment eligibility, according to the study inclusion and exclusion criteria. Consent will be obtained from patient's Legally Appointed Representative(LAR) if available, or the next of kin within 72 hours.\n\nDuration of follow up:\n\nPatient clinical status will be monitored on daily basis until 30 days after recruitment or discharge from hospital, whichever earlier.\n\nData collection:\n\nData collection will be done prospectively. All parameters collected are part of standard of care, no additional test required for the purpose of this study. Study feasibility data will be collected from screening and recruitment logs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients (≥ 21 years old),\n2. 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\n3. Patients who are not planned for any surgical procedures within 24 hours\n4. 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)\n\n * For patients with primary CNS lesions, neurologist or neurosurgeon approval will be obtained prior to recruitment.\n\nExclusion Criteria:\n\n1. Known allergy or adverse reactions from caffeine,\n2. Pregnant women,\n3. Breast-feeding women,\n4. Patients with uncontrolled cardiac arrhythmias,\n5. Patients with uncontrolled hypertension,\n6. Patients with hyperactive delirium,\n7. Patients with chronic kidney disease (CKD, any stage) who received midazolam or morphine infusion during their ICU stay,\n8. Patients who received barbiturate coma,\n9. Patients who are on theophylline, aminophylline or psychotropic agents at the point of screening for recruitment,\n10. Patients with feed intolerant, short bowel syndrome, or\n11. Patients with active seizures'}, 'identificationModule': {'nctId': 'NCT05232734', 'acronym': 'CaffeinICU', 'briefTitle': 'CaffeinICU Study - A Study on Oral Caffeine in ICU Patients With Coma', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'CaffeinICU Study - A Multi-centre Pilot Study to Examine the Safety and Feasibility of Oral Caffeine in Critically Ill Adult Patients With Low Glasgow Coma Scale Score.', 'orgStudyIdInfo': {'id': '2021/2556'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral caffeine group', 'description': 'Patients in this arm will receive treatment with oral caffeine', 'interventionNames': ['Drug: Caffeine Citrate 20 MG/ML Oral Solution']}], 'interventions': [{'name': 'Caffeine Citrate 20 MG/ML Oral Solution', 'type': 'DRUG', 'otherNames': ['Caffeine'], 'description': '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.', 'armGroupLabels': ['Oral caffeine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Sharon GK Ong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A/Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sengkang General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}