A clinical trial of the comparison of the effect of drug Na/K citrate per os plus hydration with hydration alone on serum creatinine in high-risk patients after receiving contrast
The aim of this study is investigation the effect of edible sodium potassium citrate (urine-alkalization agent utilized in treatment of uric acid kidney stones) for prevention of contrast-induced nephropathy. Patients who are participated in this research, are considered as the high-risk patients in terms of incidence of contrast-induced nephropathy for percutaneous coronary intervention. Patients who have recently received contrast, those with a left ventricular ejection fraction (LVEF) less than 30% (EF<=30%) , and those receiving diuretics are not taking part in this study. 400 patients are included randomly in either treatment or control groups. 200 patients will receive standard hydration, while the other 200 will receive edible sodium potassium citrate 2 hours before and 4 hours following the contrast intake, in addition to the intravenous hydration (urine alkalinity by Na/K citrate is investigated by urine dipstick 1 hour after oral intake) . In both groups, Serum creatinine level will be measured before and 48 hours after injection the contrast media.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011618389N3
Registration date:2015-04-30, 1394/02/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-30, 1394/02/10
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
2015-01-21, 1393/11/01
Expected recruitment end date
2016-01-22, 1394/11/02
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 drug Na/K citrate per os plus hydration with hydration alone on serum creatinine in high-risk patients after receiving contrast
Public title
Effect of Na/K citrate on contrast media-induced acute kidney injury
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria are the existence of at least one risk factor of contrast-induced nephropathy, namely: 1- Moderate systolic heart failure [ (EF) Ejection Fraction between 30-45%]2- Diabetes mellitus 3- Older than 75 year-old 4- Moderate renal insufficiency (serum creatinine level between 1/5-2 mg/dl) 5- Hypotension (systolic blood pressure less than 90 mm Hg 6- Anaemia 7- History of hypertension. Exclusion criteria; 1- pregnancy and lactation 2- History of allergic reaction to contrast media 3- Occurrence of cardiogenic shock and pulmonary edema during study 4-Urgent catheterization 5- Serum creatinine level higher than 2 mg/dl and previous history of dialysis 6- Receiving contrast medium 48 h before and after the intervention 7- Receiving diuretics, N-acetylcystein, sodium bicarbonate, theophylline, dopamine, mannitol, fenoldopam, metformin and NSAID’S during the study 8- Requiring to continue hydration therapy (e.g., sepsis condition) 9-Severe heart failure [left ventricular ejection fraction (LVEF) less than 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:
400
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
Ethics Research Committee of Qom University of Medical Sciences
Street address
Qom University of Medical Sciences and Health Services, Saheli Street, Qom
City
Qom
Postal code
Approval date
2015-01-04, 1393/10/14
Ethics committee reference number
MUQ.REC 1393.99
Health conditions studied
1
Description of health condition studied
Acute renal failure
ICD-10 code
N17
ICD-10 code description
Acute renal impairment
Primary outcomes
1
Description
serum creatinine
Timepoint
Before and 48 h after contrast intake
Method of measurement
laboratory Kit (enzymatic method)
2
Description
Urine PH
Timepoint
Before and 1 hour after citrate intake
Method of measurement
Urine dipstick
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: all of the patients will receive Na/K citrate (one hour before and four hours after contrast intake) in addition to intravenous hydration (2 litter normal saline from 2 h before to 6 h after injection of contrast media). Potassium citrate is a potassium salt of citric acid with the molecular formula C6H5K3O7. Sodium citrate has the chemical formula of Na3C6H5O7. The combination formula is sodium –potassium citrate, a white odorless crystalline powder with a saline taste. It rapidly absorbs when given by mouth and leads to urine alkalization. It is widely administered in urinary calculi (kidney stones) treatment. The drug applied in this research (trade name Na/K Citrate) is made in Iran (Sepidaj chemical company).
Category
Treatment - Drugs
2
Description
Control group: All patients will receive intravenous hydration (2 litter of normal saline From 2 h before until 6 h after the contrast intake)
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 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 2717
Fax
Email
lirani@muq.ac.irliranirad@gmail.com
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
Phone
+98 25 3612 2717
Fax
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 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 2717
Fax
Email
lirani@muq.ac.irliranirad@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)