The study of oxygen therapy in preventing contrast nephropathy in patients with acute coronary syndrome undergoing emergent angiography refereed to Resoul Akram hospital in 2018
The study of oxygen therapy in preventing contrast nephropathy in acute coronary syndrome patients undergoing emergent angiography
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, with a sample size of 204 patients
Settings and conduct
All patients were first visited and their creatinine level and arterial blood gas (ABG) were measured in emergency department of Rasoul Akram hospital. The patients were randomly divided into two groups: supplementary oxygen receiving group and the oxygen free group. The first group received 2 to 3 liters of oxygen per minute from the 10 minutes before the start of the procedure until the end of the procedure, and the second group inhaled the oxygen in the room air. ABG were taken prior to receiving oxygen and at the end of the procedure, and all ABGs were sent to the Laboratory of that center. All patients were given a same contrast. The dose of the contrast agent was at least 100 ml and maximum 200 ml. Serum creatinine level was checked for all patients before and 48 hours after the procedure.
Participants/Inclusion and exclusion criteria
Inclusion criteria including: Male or female patients over 35 years old and suspected of coronary artery disease. Non-inclusion criteria included: Arterial oxygen saturation less than 90%, having end stage renal disease, patients undergoing dialysis and candidate for emergency coronary artery bypass surgery
Intervention groups
Intervention group: Supplementary oxygen therapy
Control group: Without supplementary oxygen supply
Main outcome variables
Changes in serum creatinine level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190317043082N1
Registration date:2019-04-05, 1398/01/16
Registration timing:retrospective
Last update:2019-04-05, 1398/01/16
Update count:0
Registration date
2019-04-05, 1398/01/16
Registrant information
Name
Tahereh Zarouk Ahi Mahalleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6692
Email address
zarouk.t@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-12, 1397/05/21
Expected recruitment end date
2019-01-27, 1397/11/07
Actual recruitment start date
2018-08-12, 1397/05/21
Actual recruitment end date
2019-01-27, 1397/11/07
Trial completion date
2019-01-27, 1397/11/07
Scientific title
The study of oxygen therapy in preventing contrast nephropathy in patients with acute coronary syndrome undergoing emergent angiography refereed to Resoul Akram hospital in 2018
Public title
Effect of oxygen therapy in preventing contrast nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female patients over 35 years old
Suspected of coronary artery disease
Exclusion criteria:
Arterial oxygen saturation less than 90%
Having end stage renal disease
Patients undergoing dialysis
coronary artery bypass surgery
Candidate for emergency coronary artery bypass surgery
Age
From 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
204
Actual sample size reached:
204
Randomization (investigator's opinion)
Randomized
Randomization description
The random number table and block randomization method were used using http://www.randomizer.org. In this method, eligible patients are divided into blocks of 4 patients. We created random numbers using computer. Based on the determined numerical range to enter individuals in each group, half of the patients in each block assigned to supplementary oxygen and half of them in other group .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2016-07-22, 1395/05/01
Ethics committee reference number
IR.IUMS.FMD.REC.1397.238
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Serum creatinine level
Timepoint
Before the procedure and 48 hours later
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: : This group received 2 to 3 liters of oxygen per minute from the 10 minutes before the start of the procedure until the end of the procedure. ABG were taken prior to receiving oxygen and at the end of the procedure. The dose of the contrast agent was at least 100 ml and maximum 200 ml. Serum creatinine level was checked for all patients before and 48 hours after the procedure.
Category
Treatment - Drugs
2
Description
Control group: This group did not receive supplementary oxygen. This group inhaled the oxygen in the room air. ABG were taken prior to receiving oxygen and at the end of the procedure. The dose of the contrast agent was at least 100 ml and maximum 200 ml. Serum creatinine level was checked for all patients before and 48 hours after the procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Tahereh Zarouk Ahi Mahalleh
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8744 3210
Email
zarouk.t@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahin Akhoundzadeh
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Tahereh Zarouk Ahi Mahalleh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Number 21, Dameshgh St., Vali-e Asr Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8889 6692
Fax
Email
zarouk.t@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Zarouk Ahi Mahalleh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Number 21, Dameshgh St., Vali-e Asr Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8889 6692
Fax
Email
zarouk.t@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Zarouk Ahi Mahalleh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Number 21, Dameshgh St., Vali-e Asr Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8889 6692
Fax
Email
zarouk.t@iums.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
All potential data is shareable after being unidentifiable
When the data will become available and for how long
Up to 2019-09-01
To whom data/document is available
All university researchers
Under which criteria data/document could be used
Email
From where data/document is obtainable
Email
What processes are involved for a request to access data/document