The incidence of delirium with vitamin C judging after heart surgery
Design
A total of 180 patients will be selected based on the studies and statistical calculations that meet the inclusion criteria and then assigned to the intervention and control groups by binary blocking. In the intervention group, Vitamin C and in the control group Distilled water (as placebo) will be used. The study is a randomized, double-blind, placebo-controlled clinical trial.
Settings and conduct
Patients will be randomly divided into two groups according to the random number table.Both Vitamin C and Distilled water will be administered by the planter and with the number needed every morning before surgery begins. There will be two types of envelopes. Envelope A contains a syringe containing Vitamin C and Envelope B contains Distilled water. Each patient will receive these envelopes on the basis of an A or B code by an anesthetist who is unaware of the type of drug. In this study, the patient and the anesthetist will be blinded to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All adult patients between ages of 18 and 75 and candidates for elective cardiac surgery.
Exclusion criteria:
Previous use of anti-psychotic drugs.
Surgeries that does not use a heart or lung pump
Previous use of anti-psychotic drugs.
Patients with mental retardation.
Intervention groups
Intervention group:In this group,2 grams of vitamin C (vitamin C, 5 ml injection solution of 100 mg / 1 ml, distributed by daroo pakhsh drug factories) will be injected immediately after the start of pulmonary heart bypass (CPB)
Control group:In this group, only distilled water (as a placebo) will be prescribed with the specifications of the drugs of the intervention group.
Main outcome variables
The incidence of delirium, the severity of delirium, blood pressure and laboratory variables (sodium and potassium and ABG variables)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080830001127N7
Registration date:2020-04-17, 1399/01/29
Registration timing:registered_while_recruiting
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Eissa Bilehjani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 6124
Email address
bilehjanii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Vitamin C Supplementation on Post-Cardiac Surgery delirium
Public title
Impact of Vitamin C Supplementation on delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients between the ages of 18 and 75 and candidates for elective cardiac surgery
Exclusion criteria:
Previous use of anti-psychotic drugs
Surgeries that does not use a heart or lung pump
Previous use of anti-psychotic drugs
Patients who are not extubated until 5 days after surgery
Patients with mental retardation
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
In this study we use balanced randomization that at first four blocks with 9 combination will be formed and blocks will be numbered from 1to9. Compared to the simple randomization method, in this method the size of equilibrium of intervention and placebo groups will be established both during and at the end of study(randomization method is pre and post accidental blocks and will be done by randlist software)
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist who is responsible for the patients management of anesthesia will administer the medicine(s) via coded syringes had been prepared previously and will not be aware of the injected drug, and anesthesia nurse who is responsible for collection of patients information and study variables and is unaware of the administered drug will record the check- list during surgery and in the recovery.Also the patient is unaware of the injected medicine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915881
Approval date
2019-12-22, 1398/10/01
Ethics committee reference number
IR.TBZMED.REC.1398.1017
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05.8
ICD-10 code description
Other delirium Delirium of mixed origin Postoperative delirium
Primary outcomes
1
Description
Delirium
Timepoint
Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day
Method of measurement
Using the Richmond Agitation-Sedation Scale criterion
2
Description
Intensity of delirium
Timepoint
Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day
Method of measurement
Using CAM-ICU confusion recognition and review tools
3
Description
Blood pressure
Timepoint
Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day
Method of measurement
Using a mercury barometer
4
Description
Laboratory variables (sodium and potassium and ABG variables)
Timepoint
Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU
Method of measurement
By taking blood and determining laboratory values
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In this group, 2 grams of vitamin C (vitamin C, 5 ml injection solution of 100 mg / 1 ml, distributed by daroo pakhsh drug factories) will be injected immediately after the start of pulmonary heart bypass (CPB).
Category
Treatment - Drugs
2
Description
Control group: In this group, only distilled water (as a placebo) will be prescribed with the specifications of the drugs of the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani hospital
Full name of responsible person
Eissa Bilehjani
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
+98 41 3337 3950
Fax
+98 41 3337 3950
Email
bilehjanii@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
Research and innovation deputy, third floor, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Eissa Bilehjani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
+98 41 3337 3950
Fax
+98 41 3337 3950
Email
bilehjanii@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Eissa Bilehjani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
+98 41 3337 3950
Fax
+98 41 3337 3950
Email
bilehjanii@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Eissa Bilehjani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
+98 41 3337 3950
Fax
+98 41 3337 3950
Email
bilehjanii@tbzmed.ac.ir
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A portion of the data that represents the final outcome
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
All Physicians and residents of the department of Anesthesia
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data.
From where data/document is obtainable
Dr .Eissa Bilehjani,Madani Heart Center, Daneshgah Street, Tabriz, Tn Phone+98 41 33373950 Fax+98 41 33373950 bilehjanii@tbzmed.ac.ir
What processes are involved for a request to access data/document
Be approved by the Research Vice-President at first