| CTRI Number |
CTRI/2024/02/062623 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of coffee powder in unconscious patients |
|
Scientific Title of Study
|
Effect of caffeine on the level of consciousness in critically ill patients - A randomized clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Khartode |
| Designation |
Chief Dietitian |
| Affiliation |
Vishwaraj Hospital |
| Address |
OPD No.-7, Ground floor,
Dietetics and Nutrition department,
Vishwaraj Hospital, Near Loni station,
Pune solapur Highway-412201
Pune
MAHARASHTRA
412201
India |
| Phone |
9767133699 |
| Fax |
|
| Email |
khartode.swati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Khartode |
| Designation |
Chief Dietitian |
| Affiliation |
Vishwaraj Hospital |
| Address |
OPD No.-7, Ground floor,
Dietetics and Nutrition department,
Vishwaraj Hospital, Near Loni station,
Pune solapur Highway-412201
MAHARASHTRA
412201
India |
| Phone |
9767133699 |
| Fax |
|
| Email |
khartode.swati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Khartode |
| Designation |
Chief Dietitian |
| Affiliation |
Vishwaraj Hospital |
| Address |
OPD No.-7, Ground floor,
Dietetics and Nutrition department,
Vishwaraj Hospital, Near Loni station,
Pune solapur Highway-412201
MAHARASHTRA
412201
India |
| Phone |
9767133699 |
| Fax |
|
| Email |
khartode.swati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishwaraj Hospital,
Near Loni Station, Next To Hadapsar, Pune Solapur Highway-412201 |
|
|
Primary Sponsor
|
| Name |
Vishwaraj hospital |
| Address |
Vishwaraj Hospital, Near Loni station,
Pune solapur Highway-412201
|
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swati Khartode |
Vishwaraj Hospital |
ICU-1, ICU-2 and HDU department, 1st Floor,
Near Loni station,
Pune solapur Highway-412201
Pune
MAHARASHTRA |
9767133699
khartode.swati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERS Vishwaraj hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coffee Powder, 5 gms, Three times a day by nasogastric tube
For Study Arm |
Coffee powder 5 gms (1 teaspoon) Three times a day by nasogastric tube till the conscious level of critically ill patient improved, approximately 2-3 weeks
Total Daily dose- 15 gms of coffee powder |
| Comparator Agent |
NIL for control arm |
NIL for control arm |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Critically ill patient who is on Enteral Feed
2. Low GCS score, EMV score 3 and more
|
|
| ExclusionCriteria |
| Details |
1. Intestinal mal absorption disorders like colitis, IBS etc
2. Patients who is having Cardiac Arrhythmia |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check early improvement in conscious level with the help of glasgow coma scale (GCS) |
Till 3 weeks to 1 month, till patient gets improved GCS score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check if there is early weaning of ventilator |
2 to 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background Caffeine is a central nervous system stimulant alkaloid, that is found in various plants such as coffee, cocoa beans, tea leaves, guarana berries and the kola nut. It works as a non selective blocker of Adenosine receptors and has been related to the regulation of heart rate, the contraction and relaxation of cardiac and smooth muscles, and the neural signaling in the central nervous system. The use of adenosine receptor antagonists, such as caffeine, and agonists has been shown to protect against neurological diseases such as spinal cord injury, stroke, Alzheimer’s and Parkinson’s diseases.
Dose of Caffeine: Unsafe levels of intake, as noted previously, correspond to excessive levels, e.g., >100 mg/kg bw/day (more than 6000 mg/person/day) – associated with adverse effects resulting in acute caffeine toxicity. Such levels of caffeine may be achieved with abuse of over-the-counter (OTC) tablets and pure caffeine powder, but are not realistically achievable with consumption of caffeinated foods or beverages. It is clear that among the general population levels up to 600 mg/day and in some cases as much as 800 mg/day or more can be and are consumed every day with no ill-effect.
Absorption of Caffeine: Caffeine is generally accepted to be a mild stimulant. After oral ingestion of caffeine, mostly in the form of coffee or tea, 99% of it is absorbed from the gastrointestinal tract into the bloodstream, peaking 30–60 min after ingestion. Caffeine diffuses throughout the entire body; it passes all biological membranes, including the blood–brain barrier and the placental barrier.
Effect of caffeine on CVD: Based on
the available evidence, caffeine consumption at a variety of intake levels,
primarily in the form of tea or coffee, is generally associated with either a
statistically significant decreased risk of CVD or no statistically significant
relationship at all, even at intakes above 600 mg of caffeine per day. Among
studies reporting a protective effect with caffeine consumption, intakes
generally ranged from 100 to 400 mg per day. Several large prospective cohort
studies involving caffeine intakes up to more than 600 mg/day did not report an
increased risk of arrhythmia.
Uses in Stroke: Stroke occurs when blood flow to an individual’s brain is interrupted, causing cell death within the brain due to a lack of proper oxygenation. There was no statistically significant relationship between coffee and/or tea consumption at any level of consumption investigated and risk of stroke. Overall, the weight of evidence (28 out of 31 studies) suggests that there is no statistically significant association between caffeine consumption and the relative risk of stroke. Caffeine, a well-known antagonist of adenosinergic receptors, can be used effectively to modulate our mental state. Caffeine is found to be beneficial in restoring low levels of wakefulness and to counteract deteriorations in task performance related to sleep deprivation. However, the results also indicate that caffeine may produce detrimental effects on subsequent sleep, resulting in daytime sleepiness Level of consciousness and GCS score: Consciousness is the state of awareness of oneself and the surrounding environment and the ability to respond to external stimuli. Reduced alertness, diminished wakefulness, and a decreased awareness of oneself and the environment all characterize impaired consciousness. A coma is a profound and occasionally extended state of unconsciousness. The Glasgow Coma Scale (GCS) is a medical tool that objectively measures a coma’s severity. GCS scores are valuable in predicting the prognosis for patients with traumatic brain injuries (TBIs), subarachnoid hemorrhages, and bacterial meningitis.
Thus we have seen that caffeine is having major role as a stimulant of central nervous system, so we will conduct a study with caffeine intervention to those unconscious patients who are on enteral feed and will study if caffeine is beneficial in early improvement in their conscious level, also will check if early weaning of patients from ventilator as a secondary outcome. |