Protocol summary
-
Study aim
-
Prophylactic role of NAC and Atorvastatin in preventing contrast induced nephropathy in patients undergoing angiography with or without PCI
-
Design
-
This single blind randomized controlled trial will be performed as a community-based and pragmatic control group with parallel groups.
-
Settings and conduct
-
This investigation included 250 participants admitting for elective coronary angiography with or without percutaneous coronary intervention in Ali-ebn Abitaleb Hospital, Shiraz, Iran. After being qualified for study entrance, the patients were obtained an informed consent and were randomly categorized in 4 groups. This study is also single blind, so patients do not notified whether they were in intervention or control group.
-
Participants/Inclusion and exclusion criteria
-
Eligible patients consist of individuals older than 21 years old with abnormal renal function (creatinine clearance between 15 and 60 mL/min or serum creatinine (SCr) ≥1.1 mg/dL) undergoing elective cardiac catheterization with or without PCI.
Exclusion criteria: patients with end-stage renal failure (glomerular filtration rate (GFR) ≤ 15 mL/min); history of previous dialysis; pulmonary edema; emergency cardiac catheterization (patients with ST-segment elevation myocardial infarction undergoing primary PCI ); exposure to contrast within previous two days ago before procedure; allergies to contrast media; liver disease and contraindication to statins.
-
Intervention groups
-
These individuals were randomly categorized in 4 groups with the following features: Group I (considered as control), Group II (statin 80 mg), Group III (NAC 1800 mg) and Group IV (statin 80 mg plus NAC 1800 mg)
-
Main outcome variables
-
The primary outcome was serum creatinine alteration and the secondary clinical end point was incidence of CIN within 48 hours after contrast media exposure .
General information
-
Reason for update
-
Insufficient sample size of individuals with abnormal kidney function in this study and the start of new sampling of individuals with abnormal kidney function
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20180417039347N1
Registration date:
2018-11-20, 1397/08/29
Registration timing:
prospective
Last update:
2020-08-09, 1399/05/19
Update count:
2
-
Registration date
-
2018-11-20, 1397/08/29
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-08-22, 1399/06/01
-
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
-
Prophylactic effect of N-acetyl-cysteine plus Atorvastatin versus N-acetyl-cysteine and Atorvastatin alone for the prevention of contrast induced nephropathy in patients undergoing elective angiography with or without percutaneous coronary intervention: a single center prospective randomized controlled trial
-
Public title
-
Prophylactic effect of N-acetyl-cysteine plus Atorvastatin versus N-acetyl-cysteine and Atorvastatin alone for the prevention of contrast induced nephropathy
-
Purpose
-
Prevention
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Eligible patients include individuals older than 21 years old
abnormal renal function (Creatinine clearance between 15 and 60 mL/min or serum creatinine (SCr) ≥1.1 mg/dL)
Undergoing elective cardiac catheterization with or without PCI
Exclusion criteria:
Patients with end-stage renal failure (glomerular filtration rate (GFR) ≤ 15 mL/min),
history of previous dialysis
pulmonary edema
emergency cardiac catheterization (patients with ST-segment elevation myocardial infarction undergoing primary PCI ),
exposure to contrast within previous two days ago before procedure
allergies to contrast media,
contraindication to statins
liver disease
-
Age
-
From 21 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
250
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
In this study, random allocation method using variable blocks was used by statistical software for experimental and control groups
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
In this study, patients have been blinded about the intervention protocols .
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-09-23, 1397/07/01
-
Ethics committee reference number
-
IR.ZAUMS.REC.1397.254
Health conditions studied
1
-
Description of health condition studied
-
Contrast induced nephropathy
-
ICD-10 code
-
T80.8
-
ICD-10 code description
-
Other complications following infusion, transfusion and therapeutic injection
Primary outcomes
1
-
Description
-
Serum creatinine level altration
-
Timepoint
-
Serum creatinine levels are measured on the first day (day before the procedure) and 48 hours after exposure.
-
Method of measurement
-
creatinine test
Secondary outcomes
1
-
Description
-
incidence of CIN
-
Timepoint
-
48 h post exposure contrast media
-
Method of measurement
-
creatinine test
Intervention groups
1
-
Description
-
Intervention group: Group II was received Atorvastatin 80mg before coronary procedures (Atorvastatin 80 mg).
-
Category
-
Prevention
2
-
Description
-
Intervention group: Group III was administered N-acetylcysteine orally as a total dose of 1200 mg before and 600 mg after the coronary procedure (NAC 1800 mg).
-
Category
-
Prevention
3
-
Description
-
Intervention group: Group IV was prescribed 80 mg of Atorvastatin before the coronary procedure plus N-acetylcysteine as a sum of 1200 mg before and 600 mg after the coronary procedure (Atorvastatin 80 mg plus NAC 1800 mg).
-
Category
-
Prevention
4
-
Description
-
Control group: Group I was considered as control.They received neither Atorvastatin nor N-acetylcysteine before Coronary procedures.
-
Category
-
Prevention
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Research and technology department
-
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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available