A clinical trial of the comparison of the effect of oral Nicorandil plus hydration with hydration alone on serum creatinine in high-risk patients after receiving contrast
The aim of this study is to investigate the effect of edible Nicorandil (a vasodilator drug used to treat angina) in the prevention of contrast-induced nephropathy. Participated patients in this research candidate for percutaneous coronary intervention that are high-risk in terms of incidence of contrast-induced nephropathy. Patients who have recently received contrast, those with a left ventricular ejection fraction (LVEF) less than 30% (EF<=30%), and those receiving diuretics are eliminated from the study. 128 patients are included randomly in either treatment or control groups. 64 patients receive standard hydration, while the other 64 receive edible nicorandil 2 hours before contrast intake, in addition to the intravenous hydration. Serum creatinine is measured before and 48 hours after injection of contrast in both groups by a laboratory kit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016033118389N4
Registration date:2016-04-25, 1395/02/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-25, 1395/02/06
Registrant information
Name
Leili Iranirad
Name of organization / entity
Qom University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2712
Email address
lirani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences and Health Services Vice chancellor for research
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of the comparison of the effect of oral Nicorandil plus hydration with hydration alone on serum creatinine in high-risk patients after receiving contrast
Public title
Effect of Nicorandil on contrast media-induced acute kidney injury
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria were the existence of at least one risk factor of contrast-induced nephropathy, including 1) Moderate systolic heart failure [30% < (EF) Ejection fraction < 45%] 2) Diabetes 3) Age> 75 years 4) Moderate renal insufficiency (1/5mg/ dL< Cr < 2mg/ dL 5) Hypotension (systolic blood pressure < 90 mm Hg 6) Anemia 7) History of hypertension Exclusion criteria: 1- Pregnancy and lactation 2- Allergy to radiographic contrast 3- Have cardiogenic shock and pulmonary edema during study 4- emergency catheterization 5- Serum creatinine levels> 2 mg/dL and preexisting dialysis 6- Exposure to contrast medium 48 h pre- and post-coronary angiography 7- Receive of diuretics, N-acetylcystein, sodium bicarbonate, Theophylline, Dopamine, Fenoldopam and NSAID’S during the study 8- Needs to continuous hydration therapy (e.g., sepsis) 9-severe heart failure (EF<=30%)
Age
From 20 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block Randomization: Block randomization is commonly used in two treatment situations where sample sizes for two treatments are to be equal or approximately equal. The process involves recruiting participants in short blocks and ensuring that half of the participants within each block are allocated to treatment “B” and the other half to “C”. Conceptually there are an infinite number of possible block sizes. Suppose we consider blocks of size four. There are six different ways that four patients can be split evenly between two treatments: 1. AABB, 2. ABAB 3. ABBA, 4. BAAB, 5. BABA, 6. BBAA The next step is to select randomly among these six different blocks for each group of four participants that are recruited.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Qom University of Medical Sciences
Street address
Qom University of Medical Sciences and Health Services, Saheli Street, Qom
City
Qom
Postal code
3713649373
Approval date
2016-01-04, 1394/10/14
Ethics committee reference number
IR.MUQ.REC.1394.134
Health conditions studied
1
Description of health condition studied
Acute renal failure
ICD-10 code
N14
ICD-10 code description
Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions
Primary outcomes
1
Description
serum creatinine
Timepoint
Before and 48 h after contrast intake
Method of measurement
laboratory Kit (enzymatic method)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: All patients will be received intravenous hydration (2 liters normal saline From 2 h before to 6 h after contrast intake)
Category
Treatment - Drugs
2
Description
Intervention group: All patients will be received Nicorandil 20 mg ٰtablet (two hours before contrast intake) plus intravenous hydration (2 liter Normal saline from 2 h before to 6 h after injection of contrast). Nicorandil, a nicotinamide derivative with the molecular formula C8H9N3O4 ; Causes sustained dilation of both the arterial resistance and conductive vessels. This drug is an anti-angina medication that has the dual properties of nitrate and K+ATP channel agonist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid- Beheshti hospital
Full name of responsible person
leili Iranirad
Street address
Shahid- Beheshti hospital, Azadegan square, Qom
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences and Health Services Vice chancellor
Full name of responsible person
Hosein Saghafi
Street address
4th Ave, 1.1 Street, Safashahr st./Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences and Health Services Vice chancellor
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences, Qom, Iran
Full name of responsible person
leili Iranirad
Position
Assistant professor of Cardiology
Other areas of specialty/work
Street address
Shahid- Beheshti Hospital. Azadegan Square.
City
Qom
Postal code
Phone
+98 25 3612 2717
Fax
+98 25 3612 2154
Email
liranirad@gmail.comlirani@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Siences, Qom, Iran
Full name of responsible person
leili Iranirad
Position
Assistant professor of Cardiology
Other areas of specialty/work
Street address
Shahid- Beheshti Hospital. Azadegan Square. Qom
City
Qom
Postal code
Phone
+98 25 3612 2717
Fax
+98 25 3612 2154
Email
lirani@muq.ac.ir liranirad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences, Qom, Iran
Full name of responsible person
leili Iranirad
Position
Assistant professor of Cardiology
Other areas of specialty/work
Street address
Shahid- Beheshti Hospital. Azadegan Square. Qom
City
Qom
Postal code
Phone
+98 25 3612 2717
Fax
+98 25 3612 2154
Email
lirani@muq.ac.ir liranirad@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)