Evaluating Crocin efficacy in preventing contrast induced nephropathy
Design
This is a double blind randomized controlled trial using permuted block randomization to allocate 100 participants into two groups using the pre-designed blocks, each block consisting of a random permutation of the patient. Neither the nurse nor laboratory assistant and patients are aware of allocations. The researcher gives either Crocin or placebo for three consecutive doses to patients based on their group and will provide them with information needed, then the ward's nurse will do the standard hydration therapy 12 hrs before and after PCI and collects urine samples after each hydration therapy and BUN/Cr lab test will be ordered by the cardiologist for 72 hrs after PCI while the patient is being discharged.
Settings and conduct
This is a double blind randomized controlled trial using Permuted block randomization taking place in kermanshah city, Imam Ali heart center. Patients, nurses and laboratory assistant have been blind and only the researcher will allocate patients using permutated blocks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: coronary or peripheral angiography with or without intervention; Cr > 1.2 mg/dL and 30 <GFR < 60 mL/min; systolic pressure of greater than 90 mm Hg.
Exclusion criteria: hypersensitivity to saffron; end-stage renal disease on dialysis.
Intervention groups
Participants are divided in two groups, control and intervention group. The intervention group not only will receive 3 consecutive doses of 30 mg Crocin the night before PCI and two nights after that, but also will get standard hydration therapy based on EF either with normal saline or half saline whilst in control group we will use placebo plus standard hydration therapy based on EF.
Main outcome variables
MDRD GFR; NGAL; cystatin Creatinine GFR; Mehran Risk Score; Dose to GFR ratio; contrast volume
General information
Reason for update
Acronym
CEPCIN
IRCT registration information
IRCT registration number:IRCT20200202046335N1
Registration date:2020-05-13, 1399/02/24
Registration timing:registered_while_recruiting
Last update:2020-05-13, 1399/02/24
Update count:0
Registration date
2020-05-13, 1399/02/24
Registrant information
Name
lida shojaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6489
Email address
lida.shojaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-29, 1398/06/07
Expected recruitment end date
2020-05-27, 1399/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Crocin effect on the contrast induced nephropathy following coronary angiography or angioplasty: A randomized controlled trial
Public title
Crocin in acute kidney injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Undergoing coronary or peripheral angiography with or without intervention
Cr > 1.2 mg/dL and 30 <GFR < 60 mL/min
Systolic pressure of greater than 90 mm Hg
No contraindications to hydration or contrast agent
Exclusion criteria:
History of hypersensitivity to saffron
End-stage renal disease on dialysis
Acute renal failure
Pregnancy or lactation
Emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock
Patient receiving N-acetylcysteine or sodium bicarbonate
Platelets less than or equal to 100,000/mm3
Left Ventricular ejection fraction less than 30
History of Kidney transplant
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization is a way to randomly allocate a participant to a treatment group, while maintaining a balance across treatment groups. Each “block” has a specified number of randomly ordered treatment assignment.
For example, if you had treatment groups A and B, and you plan to enroll 20 new patients, your blocks might look like this:
B B A B A A B A B B A A B A A B B A B A
this means first patient goes to treatment group B, second patient goes to group B...
Note that each block has 10 As and 10Bs, maintaining a balance of the two despite the random order.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since both groups in this clinical trial receive standard pre-treatment hydration protocol in order to prevent contrast-induced nephropathy( CIN), first participants are provided with information regarding their risk of developing CIN and the need to hydrated enough with or without Crocin. They are told that they might benefit from taking Crocin or not, but there is no side effect for sure. Then the control group takes placebo while the intervention group takes three doses of Crocin for three days. Neither participants nor nurses and laboratory assistants are aware of allocations.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
5th floor, Kakh building, Western Khorram avenue, Golrizan street
City
Kermanshah
Province
Kermanshah
Postal code
6714657495
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.KUMS.REC.1398.1152
Health conditions studied
1
Description of health condition studied
Contrast induced nephropathy
ICD-10 code
N14.1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
urine sample collection in urine sample containers
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 3 consecutive oral doses of 30 mg crocina brand tablets. before and 24 and 48 hrs after PCI. of note is that since crocina tablets are 15 mg, each time the patient is given two tablets at the same time.
Category
Prevention
2
Description
Control group: 3 consecutive oral doses of placebo before and 24 and 48 hrs after PCI.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Heart Center
Full name of responsible person
Shima Esfandyari
Street address
5th floor, Kakh building, Western Khorram avenue, Golrizan street
City
Kermanshah
Province
Kermanshah
Postal code
6714657495
Phone
+98 83 3843 8310
Email
esfandyarishyma@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
vice chancellery for research and technology of kermanshah university of medical sciences, building number2, shahid beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714657495
Phone
+98 83 3837 0541
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Shima Esfandyari
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
5th floor, Kakh building, Western Khorram avenue, Golrizan street
City
Kermanshah
Province
Kermanshah
Postal code
6714657495
Phone
+98 83 3843 8310
Email
esfandyarishyma@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shima Esfandyari
Position
pharmacy student
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
5th floor, Kakh building, Western Khorram avenue, Golrizan street
City
Kermanshah
Province
Kermanshah
Postal code
6714657495
Phone
+98 83 3843 8310
Email
esfandyarishyma@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shima Esfandyari
Position
pharmacy student
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
5th floor, Kakh building, Western Khorram avenue, Golrizan street
City
Kermanshah
Province
Kermanshah
Postal code
6714657495
Phone
+98 83 3843 8310
Email
esfandyarishyma@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The primary outcome measure after identifying
When the data will become available and for how long
After publication
To whom data/document is available
Academic institutions and people working in businesses
Under which criteria data/document could be used
as a base for other researches
From where data/document is obtainable
Dr. Shima Esfandyari's email:
esfandyarishyma@gmail.com
What processes are involved for a request to access data/document