The purpose of this study was to compare the effect of CO2 and contrast media on the occurrence of nephropathy in patients undergoing angiography or angioplasty of the lower extremity.
Design
A single-blind, parallel controlled, randomized clinical trial is performed on 166 eligible patients.
Settings and conduct
This study is single blind and patients are not aware of the type of intervention.Both groups receive Ejection Fraction (EF) -based hydration 12 hours before the procedure and 6 hours after the procedure. Patients in the co2 group receive a maximum of 60 cc of CO2 gas with a maximum of 20 cc of contrast agents (if needed) during diagnostic or therapeutic action. The contrast-receiving group will be diagnosed or treated with a maximum of 500 cc through the artery sheath.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years Estimated Glomerular filtration rate (GFR) greater than 30 ml / min /1.73 m2 based on Modification of Diet in Renal Disease (MDRD) equation.
Exclusion criteria:
Contact contrast over the past month Patients with intracardiac shunt, History of kidney or heart transplantation, More than 15% change in serum creatinine level over the past two days, Patients undergo regular hemodialysis, Patients with a history of proteinuria and Cirrhotic patients.
Intervention groups
Patients groups: 1.angiography or angioplasty of the lower extremities with CO2 gas
2.angiography or angioplasty of the lower extremities with contrast media.
Main outcome variables
Contrast induce acute kidney injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191107045359N1
Registration date:2019-12-18, 1398/09/27
Registration timing:registered_while_recruiting
Last update:2019-12-18, 1398/09/27
Update count:0
Registration date
2019-12-18, 1398/09/27
Registrant information
Name
Batoul Naghavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2266 3246
Email address
naghavirhc@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of carbon dioxide gas and contrast agent on kidney function in patients peripheral vascular disease
Public title
The effect of carbon dioxide gas on the occurrence of nephropathy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Estimated GFR greater than 30 ml / min /1.73 m2 based on MDRD equation
Exclusion criteria:
Contact contrast over the past month
Patients with intracardiac shunt
History of kidney or heart transplantation
More than 15% change in serum creatinine level over the past two days
Patients undergo regular hemodialysis
Patients with a history of proteinuria
Cirrhotic patients
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
166
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
The computer generates random numbers between 0 and 1.
If the random number is less than 0.500, the person enters group T.
If the random number is greater than 0.500, the person enters group C.
Blinding (investigator's opinion)
Single blinded
Blinding description
After obtaining informed consent, patients are divided into two groups based on random numbers, but the patients do not know which groups they belong to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rajaie Cardiovascular, Medical and Research Center
Street address
Vali Asr Ave, Next to Mellat Park, Rajaie Cardiovascular, Medical and Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2019-10-26, 1398/08/04
Ethics committee reference number
IR.RHC.REC.1398.055
Health conditions studied
1
Description of health condition studied
Peripheral vascular diseases
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Contrast induce acute kidney injury.Nephropathy will be defined based on a 25% or 0.5 mg / dl increase in serum creatinine.
Timepoint
Before intervention and 48 hours after intervention.
Method of measurement
laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Angiography or angioplasty with CO2 gas
Category
Diagnosis
2
Description
Control group: Angiography or angioplasty with contrast media
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular, Medical and Research Center
Full name of responsible person
Batool Naghavi
Street address
Vali Asr Ave, Next to Mellat Park, Rajaie Cardiovascular, Medical and Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
naghavirhc@gmail.com
Web page address
http://rhc.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular, Medical and Research Center
Full name of responsible person
Dr.Fereidoun Nouhi
Street address
Valiasr Ave, Rajaie Cardiovascular, Medical and Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
Naghavirhc@gmail.com
Web page address
http://rhc.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular, Medical and Research Center
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
Iran University of Medical Sciences
Full name of responsible person
Batoul Naghavi
Position
Cardiologist
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Hashemi rafsanjani highway,Rajaie Cardiovascular, Medical and Research Center.postal code :1995614331
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2266 3246
Fax
Email
naghavirhc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Batoul Naghavi
Position
Cardiologist
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Hashemi rafsanjani highway,Rajaie Cardiovascular, Medical and Research Center.postal code :1995614331
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2266 3246
Fax
Email
naghavirhc@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Batoul Naghavi
Position
Cardiologist
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Hashemi rafsanjani highway,Rajaie Cardiovascular, Medical and Research Center.postal code :1995614331
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2266 3246
Fax
Email
naghavirhc@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD