The effect of sodium chloride hydration with and without allopurinol on prevention of contrast-induced nephropathy in high risk patients undergoing coronary angiography
Despite the use of low-osmolarity contrast media and prophylactic hydration, contrast-induced nephropathy remains a potentially serious complication of coronary angiography. So this study will be conducted in order to evaluate the effect of allopurinol on prevention of contrast-induced nephropathy in high risk patients undergoing coronary angiography. In this prospective randomized clinical trial, 140 patients with at least one risk factor of nephropathy will be divided to allopurinol plus sodium chloride hydration group (Intervention group; n =70) or to standard intravenous isotonic saline hydration group randomly (Control group; n = 70). Randomization will be performed with block randomization. Serum Creatinine, Blood urea nitrogen (BUN), CRP and Uric Acid will be measured before administration of contrast agent and at 48 h after injection of contrast agent.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072318389N2
Registration date:2014-09-24, 1393/07/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-24, 1393/07/02
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
Vice chancellor for research, Qom University of Medical Sciences and Health Services
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sodium chloride hydration with and without allopurinol on prevention of contrast-induced nephropathy in high risk patients undergoing coronary angiography
Public title
The effect of Allopurinol on prevention of contrast-induced nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients, who have at least one of the following risk factors: 1) Heart failure (25%<ejection fraction<40%) 2) diabetes 3) Age >75 years 4) Renal insufficiency (creatinine 1.5mg/dl) 5) Hypotension (SBP<80 mm Hg for 1 hour) 6) GFR<60/mL/min per 1.73 m2 7) Anemia 8) hypertension 9) Pulmonary edema Exclusion criteria: 1- Pregnancy and lactation 2- Allergy to radiographic contrast 3- Have cardiogenic shock and pulmonary edema during study 4- multiple myeloma, pulmonary ventilation and emergency catheterization 5- Serum creatinine levels< 4 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, Mannitol, Fenoldopam, Metformin and NSAID’S during the study 8- Needs to continuous hydration therapy (e.g., sepsis)
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
140
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 and Health Services
Street address
Qom University of Medical Sciences and Health Services, Saheli Street, Qom
Interventional group: All patients will be received allopurinol (100mg, TDS) 24 h before administration of contrast agent plus intravenous hydration (1mg /kg/h Normal saline for 12 h pre- and post-contrast)
Category
Treatment - Drugs
2
Description
Control group: All patients will be received intravenous hydration (1 mL/kg/ h) Normal saline for 12 h pre- and post-contrast.
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 for research
Full name of responsible person
Hossian 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 for research
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 and Health Services
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 2733
Fax
+98 25 3612 2154
Email
lirani@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences and Health Services
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
3716987366
Phone
+98 25 3612 2733
Fax
+98 25 3612 2154
Email
lirani@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences and Health Services
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 2154
Fax
Email
lirani@muq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)