Determining the effect of determining the effect of Piracetam compared to placebo in preventing delirium in inpatients admitted to the intensive care unit.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 80 patients.
Settings and conduct
The intervention will start from the moment the patient is admitted to the intensive care unit. Piracetam or placebo tablets are kept in a coded sealed envelope. After randomizing the patients, each package will be randomly opened in front of the patient. The patients, the person providing the treatment, and the person responsible for the statistical analysis are not aware of the contents of the package (blinded).
Participants/Inclusion and exclusion criteria
Medical ICU patients, aged between 18 and 80 years, with the condition of consent to participate in the plan. Pregnant patients, burn cases and special surgical care, COVID19 patients are not eligible.
Intervention groups
Patients in the Piracetam group (intervention) will receive 800 mg orally every 8 hours for 7 days. Patients in the control group (placebo) will receive a placebo pill every 8 hours for 7 days.
Main outcome variables
The primary outcome includes: the effect of the drug on the occurrence of delirium, which is measured through daily evaluation via confusion assessment method (CAM-ICU).
General information
Reason for update
Acronym
EPPDICU
IRCT registration information
IRCT registration number:IRCT20240105060618N1
Registration date:2024-04-12, 1403/01/24
Registration timing:prospective
Last update:2024-04-12, 1403/01/24
Update count:0
Registration date
2024-04-12, 1403/01/24
Registrant information
Name
Yeganeh Abedipor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 805 0154
Email address
yeg.abedipor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-06-18, 1403/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of piracetam compared to placebo in preventing delirium in patients admitted to the intensive care units
Public title
Effect of piracetam in preventing delirium in ICU patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 80
Consent to participate
Medical ICU case
Exclusion criteria:
Pregnancy
COVID-19 patients
Surgical and burn ICU cases
APACHE score >28 in the ICU admission
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly allocate patients in two groups, the block method is used, thus the number of blocks will be 4.Patients were assigned to blocks of 4 using random numbers. Then each block was assigned to a code and each code was packed in a sealed envelope along with the medicatiosn. The envelope was opened in front of the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before the project begins, a pharmacist will pack all pills in the same opaque envelopes. Each envelope will contain a code. Only the principal investigator knows the connection between the codes and the contents inside the envelope. We will open the envelopes in front of the patients after they have signed the informed consent form and undergone randomization.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of the Imam Khomeini Hospital Complex, Tehran University of Medical Scien
Street address
Tehran Province, Tehran, District 6, Pour Sina St, P94V+8MF, Iran
City
Teharn
Province
Tehran
Postal code
1417613151
Approval date
2023-12-22, 1402/10/01
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.382
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium (positive confusion assessment method)
Timepoint
The first 7 days of ICU admission
Method of measurement
Confusion assessment method
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Placebo (1 pill every 8 hours for 7 days). Patients in this group will receive a placebo tablet with a glass of water every 8 hours. This intervention continues from the beginning of the patient's admission to the 7th day of hospitalization in the intensive care unit.
Category
Treatment - Drugs
2
Description
Intervention group: Piracetam (800 mg every 8 hours for 7 days). Patients in this group will receive one pill of Piracetam 800 mg with a glass of water every 8 hours. This intervention continues from the beginning of the patient's ICU admission to the 7th day of hospitalization in the intensive care unit.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Yeganeh Abedipor
Street address
No 21, Dameshgh St., Vali-e Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8889 6696
Email
yeg.abedipor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Sari
Street address
Tehran Province, Tehran, District 6, Pour Sina St, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8889 6696
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Yeganeh Abedipor
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 21, Dameshgh St., Vali-e Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 912 805 0154
Fax
Email
yeg.abedipor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Yeganeh Abedipor
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 21, Dameshgh St., Vali-e Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 912 805 0154
Fax
Email
yeg.abedipor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Yeganeh Abedipor
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 21, Dameshgh St., Vali-e Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 912 805 0154
Fax
Email
yeg.abedipor@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data will be coded and will be shared upon reasonable request to corresponding author.
When the data will become available and for how long
Starting in January 2025
To whom data/document is available
Clinical investigators and people working in academic institutions
Under which criteria data/document could be used
Clear plan or justification for using the data.
From where data/document is obtainable
Email Dr.Abedi.
What processes are involved for a request to access data/document
Email should be sent from an academic institutions and 1 month will be lasted from sending email and getting data.