The association between vitamin D medication therapy and reducing post coronary bypass graft surgery acute kidney injury in patients with low vitamin D levels.
Evaluation the effect of vitamin D prescription on early complications of CABG surgery such as AKI by KIM-1 , IL-18urinary levels.
Design
Interventional clinical trial has controll and intervention groups,parallel group trial,randomization was computerized,clinical trial is double blind and community based.
Settings and conduct
Method of randomization is simple .unit of randomization is individual. The tool of randomization is computer software.this study is double blinded and the participants in study,care providers, investigators and data analysers are blinded.study is about connection between vitamin D level and CS-AKI in patients is going to have CABG in modarres hospital measured by IL18,KIM1 urinary levels.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1.CABG surgery for the first time.
2.The patient who has just CABG surgery without another surgery like valvular replacement at the same time.
3.CPB usage in surgery.
4.Patients with vitamin D level less than 20 ng/m.
exclusion criteria:
1.Taking vitamin D supplement.
2.ESRD or cr level more than 1.5 mg/dl.
3.Taking nephrotoxic drugs.
4.Less than 3 days gap between angiography and surgery.
Intervention groups
We designed 2 groups:
1. intervention group .
2. observation group.
In intervention group ,we prescribed pearl vitamin D 50000 units 3 times a day for 3 days before the surgery . in observation group we prescribed placebo instead of vitamin D in similarly.
Main outcome variables
1.The renal markers' (IL-18,KIM-1) changes under the effect of vitamin D as a protective subject.
2. vitamin D effect on bleeding in no time , 6 hours , 12 hours after surgery
3. vitamin D effect on ventilation after CABG surgery .
4.vitamin D effect on transfusion after CABG surgery.
5.Creatinine levelsin no time before the surgery, after surgery and the day after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180131038578N1
Registration date:2019-03-20, 1397/12/29
Registration timing:registered_while_recruiting
Last update:2019-03-20, 1397/12/29
Update count:0
Registration date
2019-03-20, 1397/12/29
Registrant information
Name
Pegah Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4609 4291
Email address
pegahslm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
empty
Scientific title
The association between vitamin D medication therapy and reducing post coronary bypass graft surgery acute kidney injury in patients with low vitamin D levels.
Public title
The effect of preoperative and postoperative vitamin D medication therapy on postoperative urinary IL18,KIM1levels in modarres hospital CABG patients in 1397 year
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
CABG surgery for the first time.
The patient who had just CABG surgery without another surgery at the same time, like valvular replacement.
CPB usage in the surgery.
Patients with vitamin D level less than 20 ng/ml.
Exclusion criteria:
Taking vitamin D supplements before the study.
ESRD or cr level more than 1.5 mg/dl
Taking nephrotoxic drugs.
Less than 3 days gap between angiography and surgery.
Age
From 18 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
66
More than 1 sample in each individual
Number of samples in each individual:
4
We will have 4 samples for measurement of IL18,KIM1 of each member: 1. Before surgery (basic). 2.in the operation room. 3.After surgery. 4.first day after surgery.
Actual sample size reached:
66
More than 1 sample in each individual
Actual sample size in each individual:
4
We have 4 samples of each member:1. Before surgery measurement of IL18,KIM1 (basical) 2.in the OR at the same time of surgery for IL18,KIM1 measurement . 3.After surgery 4.first day after surgery
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is simple .unit of randomization is individual. The tool of randomization is computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blinded and the participants in study,care providers, investigators and data analysers are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of shahid beheshti university of medical sciences
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.SBMU.MSP.REC.633
Health conditions studied
1
Description of health condition studied
Post coronary artery bypass graft surgery acute kidney injury
ICD-10 code
N99.0
ICD-10 code description
Postprocedural (acute) (chronic) kidney failure
Primary outcomes
1
Description
The renal injury marker urinary level interlukin-18.
Timepoint
Before the surgery, in no time after surgery , a day after surgery.
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
2
Description
The renal injury marker urinary level,kidney injury molecule-1.
Timepoint
Before the surgery, in no time after surgery , a day after surgery.
Method of measurement
The enzyme-linked immunosorbent assay (ELISA).
Secondary outcomes
1
Description
Bleeding .
Timepoint
In no time , 6 hours , 12 hours after surgery 2.
Method of measurement
Collected by chest tube by ML/Hour
2
Description
Ventilation .
Timepoint
During 12 hours after CABG surgery.
Method of measurement
Ventilator for ventilation measuring by per hour
3
Description
Packed RBC cell transfusion .
Timepoint
During 12 hours after CABG surgery .
Method of measurement
packed RBC cell bag for transfusion.
4
Description
Creatinine serum levels .
Timepoint
In no time before the surgery, after surgery and the day after surgery.
Method of measurement
Laboratory test for creatinine.
Intervention groups
1
Description
Intervention group: is going to be prescribed 50000 units vitamin D for 3 consecutive days , 3 times a day. vitamin D level ,IL18,KIM1is going to be measured before the surgery.IL18,KIM1is going to be measured during the surgery, the day after surgery in both groups
Category
Prevention
2
Description
Control group: is going to be prescribed placebo for 3 consecutive days , 3 times a day,vitamin D level ,IL18,KIM1is going to be measured before the surgery.IL18,KIM1is going to be measured during the surgery, the day after surgery