The comparison of normal saline, ringer lactate and sodium bicarbonate for prevention of contrast induced nephropathy in the patients who underwent coronary angiography in Shiraz
The aim of this study is to compare the efficacy of normal saline, Ringer lactate and sodium bicarbonate in preventing contrast induced nephropathy in patients undergoing coronary angiography. This is a double-blind, unicenter, non-placebo-controlled study in 300 patients over 18 years old who have indication for coronary angiography. Patients with hemodynamic instability, severe heart failure, pulmonary edema, electrolyte and acid-base disorders and patients under dialysis are not included. Furthermore, Patients experiencing any unwanted complication during or after angiography are excluded from the study. Patients are divided into 3 groups using simple randomization method. The first group receives normal saline 0.9% while the second group and the third one receive Ringer lactate and sodium bicarbonate solution respectively as intravenous injection. Fluids are administered by 3 ml/kg one hour before angiography and 1 ml/kg/hour for 6 hours after the angiography. All patients receive N-acetylcysteine tablet orally twice a day from 1 day before to 1 day after angiography. Metformin and diuretics administration is stopped before the study. Creatinine increase greater than 0.3 mg/dl or more than 25% compared to serum baseline is valuable. Tests for potassium, sodium, creatinine, blood urea nitrogen, and urine pH and estimated glomerular filtration rate are evaluated before and after angiography and the consequences in terms of prevention of kidney disorders are observed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080323483N1
Registration date:2016-10-21, 1395/07/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-21, 1395/07/30
Registrant information
Name
Zahra Salmanpour
Name of organization / entity
Shiraz University of Medical Sciencies
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 5610
Email address
salmanpur@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental, Sums research center
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of normal saline, ringer lactate and sodium bicarbonate for prevention of contrast induced nephropathy in the patients who underwent coronary angiography in Shiraz
Public title
The comparison of different types of fluid therapy in prevention of contrast induced renal malfunction in coronary angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients over 18 y/o who have indications for coronary angiography and angioplasty are included. However, patients with hemodynamic instability, severe cardiac failure or pulmonary edema, under dialysis, under medications potentially affecting kidney function or with electrolyte and acid-base disturbances are not included.
Exclusion criteria: patients with undesired complications such as arterial dissection during angiography or angioplasty are excluded from the study.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, both physician and patients were unaware of the nature of the therapy; therefore, it is considered as a double blind study.
randomization method: for each patient, a code will be generated by using random-numbers table.If the ones of the code is (1,2,3) the patient will be placed in the first group (normal saline). If the ones of the code is (4,5,6) or (7,8,9) the patient will be categorized in the second (ringer lactate) and third group (sodium bicarbonate) respectively. In addition the codes with ones equal to zero will be deleted.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Blvd. Shiraz
City
Shiraz
Postal code
Approval date
2015-07-12, 1394/04/21
Ethics committee reference number
IR.SUMS.REC.1394.71
Health conditions studied
1
Description of health condition studied
contrast induced nephropathy
ICD-10 code
N14.1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
Creatinine
Timepoint
before and 48 hours after intervention
Method of measurement
Jaffe with adsorbent (picrate) method
2
Description
BUN
Timepoint
before and 48 hours after intervention
Method of measurement
urease/GLDH method
3
Description
urine PH
Timepoint
before and 6 hours after intervention
Method of measurement
PH meter sticks
4
Description
estimated GFR (eGFR)
Timepoint
before and 48 hours after intervention
Method of measurement
MDRD equation
Secondary outcomes
1
Description
Sodium and Potassium (Na and K)
Timepoint
before and 48 hours after intervention
Method of measurement
flame photometry method
Intervention groups
1
Description
Intervention 1: In this group, the patients receive intravenous normal saline (0.9%) at a rate of 3 ml/kg one hour before angiography and 1 ml/kg per hour for 6 hours after angiography.
Category
Prevention
2
Description
Intervention 2: In this group, the patients receive intravenous ringer lactate at rate of 3 ml/kg one hour before angiography and 1 ml/kg per hour for 6 hours after angiography.
Category
Prevention
3
Description
Intervention 3: In this group, the patients receive intravenous sodium bicarbonate (850 ml DW 5% plus 150 mEq sodium bicarbonate) at a rate of 3 ml/kg one hour before angiography and 1 ml/kg per hour for 6 hours after angiography.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi hospital
Full name of responsible person
Street address
Zand Blvd. Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr.S.B. Hashemi
Street address
Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research, Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. M. Pakfetrat
Position
nephrologist
Other areas of specialty/work
Street address
Internal medicine department, Namazi hospital, Namazi square
City
Shiraz
Postal code
Phone
00
Fax
Email
pakfetratm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. M. Pakfetrat
Position
nephrologist
Other areas of specialty/work
Street address
Internal medicine department, Namazi hospital, Namazi sq.
City
Shiraz
Postal code
Phone
+98 71 3612 5610
Fax
Email
pakfetratm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)