Objectives: the aim of this study was to assess the effectiveness of aminophylline for prevention of renal impairment after cardiac surgery. Inclusion criteria: all patients undergoing cardiac surgery and can use Aminophylline. Research Design: Conduction of a randomized, double-blind, clinical trial, method of randomization: simple.
Exclusion criteria: patients with cardiac arrhythmia, tachycardia, and patients with kidney damage in case of non- oliguric, daily urine of patients who have obstructive uropathy, patients with congenital renal anomalies. One hundred and fourthly-four patients undergoing cardiac surgery were risk stratified as per Cleveland score to assess for prediction of AKI(acute kidney injury). 72 patients in the intervention group received a bolus aminophylline of 5 mg/kg and a subsequent continuous infusion of 0.25 mg/kg/h for up to 48 h, while, 72 Patients of control group just received usual postoperative care. Serum creatinine concentrations were measured preoperatively and daily until 2 days after surgery and the glomerular filtration rate estimated using Cockcroft and Gault formula. Hourly urine output was recorded and patients assigned to respective RIFLE stage of AKI. Cleveland score ≥6 was associated with higher incidence of AKI: I and F. Number needed to treat, an insight into the clinical relevance of a specific treatment, is 8.
Vice Chancellor for Research, Shiraz University of Medical
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Aminophylline on Renal Function after Cardiac Surgery
Public title
The Effect of Aminophylline on Renal after Cardiac Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients undergoing cardiac surgery and can use Aminophylline.
Exclusion criteria: patients with cardiac arrhythmia, tachycardia , patients with kidney damage in case of non oliguric, daily urine of patients who have obstructive uropathy, patients with congenital renal anomalies
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
CP-P-9374-7224
Health conditions studied
1
Description of health condition studied
Cardiac Surgeries
ICD-10 code
197.1
ICD-10 code description
Cardiac insufficiency Heart failure following cardiac surgery or due to presence of cardiac prosthesis
Primary outcomes
1
Description
Diagnosis of Kidney Damage
Timepoint
Daily measurement: On the days before and after surgery and the second and third days after surgery.
Method of measurement
RIFLE scale: It based on the amount of creatinine and GFR calculated by the amount of kidney damage.
Secondary outcomes
1
Description
Diagnosis of Kidney Damage
Timepoint
Daily measurement: On the days before and after surgery and the second and third days after surgery
Method of measurement
Urine Output
Intervention groups
1
Description
Patients in the intervention group received a bolus aminophylline of 5 mg/kg before the surgery and a subsequent continuous infusion of 0.25 mg/kg/h for up to 48 h after the surgery.
Category
Treatment - Drugs
2
Description
Control group: patients in the control group didn't take aminophylline.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Peyman Alishahi
Street address
Ghasrodasht Street
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 Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
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
Peyman Alishahi
Position
Physician, Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
alishahi_p@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
Shahrbano Shahbazi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
sh_shahbazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
English Consultant,Anesthesiology Research Center Staff
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)