Protocol summary

Summary
Objectives: Determination of the rate of ‎acute kidney injury incidence, following ‎fluid ‎resuscitation with isotonic saline ‎compared to Ringer lactate in patients ‎undergoing off-pump ‎coronary bypass, ‎hospitalized in the intensive care unit ‎‎(ICU).‎ Design: Randomized clinical trial, ‎single blind, Target sample size: 966 ‎people. Inclusion criterion to ‎study: patients after undergoing elective ‎off-pump coronary ‎bypass.‎ Exclusion criteria from study: Emergency ‎surgical operation; Previous history of ‎‎cardiac surgery; American Society of ‎Anesthesiologists Class ( ASA) more than ‎‎4; Previous history of ‎kidney diseases; ‎Diabetic nephropathy; Preoperative serum ‎creatinine level more than 1.3; ‎‎Preoperative glomerular filtration rate ‎‎(GFR) less than 75%, 8) preoperative ‎ejection fraction ‎‎(EF) less than 30%; ‎Drainage more than the volume during ‎the surgery; Use of a balloon pump ‎‎during or after the surgery; Prolonged ‎recurrent ventricular fibrillation (VF) ‎during the surgery; ‎High dose inotrope ‎‎(inotrope 2) during the surgery; Lack of ‎patient’s consent to participate in ‎the ‎study.‎ Patients are also excluded during ‎the study period if hyperchloremia (CL ‎more than 110) occurs ‎in the ICU, Various ‎complications might occur (hemorrhage, ‎drainage, cardiac arrest, ‎prolonged ‎hemodynamic instability, and neurological ‎complications of CVA), which result in the ‎‎exclusion of patients from the study.‎ Control group: Isotonic saline 0.9% containing 154 mEq chlorine ion, 40 CC/kg at 24 hours after surgery Intervention group: Ringer lactate containing 109 mEq chlorine ion, 40 CC/kg at 24 hours after surgery. Primary outcome: Arterial blood gases, Before and at the first 24 hours after intervention, every 4 hours, By Blood test; Blood urea nitrogen‎, Before and after intervention, daily by blood test, venous blood samples from the arm; Blood creatinine level, daily by blood test in jaffe method.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041813159N2
Registration date: 2014-06-15, 1393/03/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-06-15, 1393/03/25
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2014-06-28, 1393/04/07
Expected recruitment end date
2015-05-28, 1394/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the rate of acute kidney ‎injury incidence, following fluid ‎resuscitation with ‎isotonic saline ‎compared to Ringer lactate in patients ‎undergoing on-pump coronary bypass, ‎‎hospitalized in the intensive care unit ‎‎(ICU) ‎
Public title
Diagnosis of acute kidney injury in patients undergoing on-pump coronary artery bypass
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: ‎patients after undergoing elective on-‎pump coronary ‎bypass.‎ Exclusion criteria: Emergency ‎surgical operation; Previous history of ‎‎cardiac surgery; American Society of ‎Anesthesiologists Class ( ASA) more than ‎‎4; Previous history of ‎kidney diseases; ‎Diabetic nephropathy; Preoperative serum ‎creatinine level more than 1.3; ‎‎Preoperative glomerular filtration rate ‎‎(GFR) less than 75%; preoperative ‎ejection fraction ‎‎(EF) less than 30%; ‎Drainage more than the volume during ‎the surgery; Use of a balloon pump ‎‎during or after the surgery; Prolonged ‎recurrent ventricular fibrillation (VF) ‎during the surgery; ‎High dose inotrope ‎‎(inotrope 2) during the surgery; Lack of ‎patient’s consent to participate in ‎the ‎study.‎ Patients are also excluded during ‎the study period if hyperchloremia (CL ‎more than 110) occurs ‎in the ICU, Various ‎complications might occur (hemorrhage, ‎drainage, cardiac arrest, ‎prolonged ‎hemodynamic instability, and neurological ‎complications of CVA), which result in the ‎‎exclusion of patients from the study.‎ ‎
Age
From 20 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 966
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Male and female subjects, undergoing coronary artery bypass (off-pump) surgery for the first time, were randomly allocated to two groups (block method). Researchers are unaware.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2013-11-23, 1392/09/02
Ethics committee reference number
920804

Health conditions studied

1

Description of health condition studied
Kidney injury
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified

Primary outcomes

1

Description
Arterial blood gases
Timepoint
Before intervention and at the first 24 hours after intervention, every 4 hours
Method of measurement
Blood test

2

Description
Blood urea nitrogen‎
Timepoint
Before and after intervention, daily
Method of measurement
Blood test, venous blood samples from the arm

3

Description
Blood creatinine level
Timepoint
After intervention, daily
Method of measurement
Blood test in jaffe method

4

Description
Sodium
Timepoint
Before intervention and at the first 24 hours after intervention, every 4 hours
Method of measurement
Blood test

5

Description
Lactate
Timepoint
Before and after intervention, daily
Method of measurement
Blood test

Secondary outcomes

1

Description
Chlorine
Timepoint
Before surgery and after surgery Daily
Method of measurement
Blood test

Intervention groups

1

Description
Control group: Isotonic saline 0.9% containing 154 mEq chlorine ion, 40 CC/kg at 24 hours after surgery
Category
Diagnosis

2

Description
Intervention group: : Ringer lactate containing 109 mEq chlorine ion, 40 CC/kg at 24 hours after surgery.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Siamak Boustan
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
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, Mashhad 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
Mashhad University of Medical sciences
Full name of responsible person
Siamak Boustan
Position
Practitioner
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza square, Mashhad
City
Mashhad
Postal code
Phone
0098935‏8937544‏
Fax
Email
professorsiamak@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
sheybanish@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
sheybanish@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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