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Investigating the relationship between the duration of rewarming patients and the incidence of acute kidney injury after coronary artery bypass

Protocol summary

Study aim
Determining the relationship between the duration of rewarming patients and the incidence of acute kidney injury after coronary artery bypass surgery
Design
A randomized, single-blinding clinical trial, with the parallel groups, Phase 3 on 80 patients
Settings and conduct
In this randomized, single-blind clinical trial study, 80 eligible patients referred to Chamran Hospital in Isfahan will be enrolled in the study and randomly divided into two groups. Rewarming of patients in the first group will be done at a fast rapid and in the second group at a slow rapid. In this study, the interventionist is aware of the type of intervention in each group, but the patient, researcher, and statistical analyst will not be aware of the type of intervention. Then, the incidence of acute kidney injury and blood parameters of the patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients who were candidates for elective coronary artery bypass grafting, aged 40 to 75 years, EF greater than 40%, and written consent to participate in the study. Exclusion criteria included the creatinine level greater than 1.4 mg/dl before surgery, candidate for multiple surgeries simultaneously, need emergency surgery, reoperation, history of angiography in the past 72 hours, history of stroke, history of any kidney disease.
Intervention groups
Intervention group: In this group the patient is rewarmed to a temperature of 37°C with a maximum gradient of 10°C between the nasopharyngeal temperature and the warm water (Fast rate group). Control group: In this group, the patient is rewarmed to a temperature of 37°C with a maximum gradient of 5°C between the nasopharyngeal temperature and the warm water (Slow rate group).
Main outcome variables
Acute kidney injury; Creatinine; Urine output; Glomerular Filtration Rate(GFR); Complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N83
Registration date: 2025-08-16, 1404/05/25
Registration timing: prospective

Last update: 2025-08-16, 1404/05/25
Update count: 0
Registration date
2025-08-16, 1404/05/25
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-21, 1404/06/30
Expected recruitment end date
2026-01-21, 1404/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the relationship between the duration of rewarming patients and the incidence of acute kidney injury after coronary artery bypass
Public title
Relationship between the duration of rewarming patients and the incidence of acute kidney injury after heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients eligible for elective coronary artery bypass grafting Age range 40 to 75 years EF greater than 40% Written consent to participate in the study
Exclusion criteria:
Having a creatinine level more than 1.4 mg/dl before surgery or EGFR < 60 ml/min/1.73 m2 Patients who are candidates for multiple surgeries at the same time (such as valve replacement and Coronary artery bypass) Patients who require emergency surgery Reoperation Having a history of angiography in the last 72 hours Having a history of stroke or any neurological disease Performing dialysis before surgery or chronic chronic kidney disease or a history of any kidney disease
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 80 eligible patients are randomly selected. For this, the letter A is written on 40 sheets, and the letter B is written on 40 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to comply with the blinding conditions, due to the difference in the intervention method in each group to adjust the speed of rewarming of the patient, the interventionist is aware of the type of intervention in each group. It should be noted that it has also been explained to the patient before including the study that one of the two rewarming methods will be performed for them by chance and they may be placed in one of the two groups and if they consent, they will be entered into the study. Therefore, the patient undergoes this process during surgery and therefore will not be aware of the type of intervention. Also, the person collecting the data and the statistician will not have any knowledge of the type of intervention in each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2025-04-14, 1404/01/25
Ethics committee reference number
IR.MUI.MED.REC.1404.027

Health conditions studied

1

Description of health condition studied
Coronary artery bypass surgery
ICD-10 code
I25.810
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) without angina pectoris

Primary outcomes

1

Description
Creatinine
Timepoint
Before surgery, the first, second, third, and seventh days after surgery
Method of measurement
Blood test

2

Description
Urine output
Timepoint
Before surgery, the first, second, third, and seventh days after surgery
Method of measurement
Volume of urine in the urine bag

3

Description
Glomerular Filtration Rate(GFR)
Timepoint
Before surgery, the first, second, third, and seventh days after surgery
Method of measurement
Based on formula: [175 × Serum Cr ^(-1.154)] × [age ^ (-0.203) × 1.212]

4

Description
Acute kidney injury
Timepoint
After surgery
Method of measurement
Based on the Kidney Disease: Improving Global Outcomes (KDIGO) criteria

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, patients are cannulated in the ascending aorta and right atrium after systemic heparinization. Cardiopulmonary bypass is performed under mild hypothermia (30°C). Mean arterial pressure is maintained at 80-90 mmHg throughout the coronary artery bypass. After the last distal anastomosis, rewarming is performed to 37°C with a maximum gradient of 10°C between nasopharyngeal temperature and warm water (rapid rate group).
Category
Treatment - Surgery

2

Description
Control group: In this group, patients are cannulated in the ascending aorta and right atrium after systemic heparinization. Cardiopulmonary bypass is performed under mild hypothermia (30°C). Mean arterial pressure is maintained at 80-90 mmHg throughout the coronary artery bypass. After the last distal anastomosis, rewarming is performed to 37°C with a maximum gradient of 5°C between nasopharyngeal temperature and warm water (slow speed group).
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Mahmood Saeidi
Street address
2nd Moshtagh Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
saeidi6696@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahmoud Saeidi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Department of Cardiac Surgery, Shahid Chamran Hospital, Mushtaq Street
City
Isfahan
Province
Isfehan
Postal code
81583-88997
Phone
+98 31 3260 0961
Fax
Email
saeidi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahmoud Saeidi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Department of Cardiac Surgery, Shahid Chamran Hospital, Mushtaq Street
City
Isfahan
Province
Isfehan
Postal code
81583-88997
Phone
+98 31 3260 0961
Email
saeidi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadbagher Ghasemi
Position
Senior student of blood circulation technology
Latest degree
Bachelor
Other areas of specialty/work
Blood circulation technology
Street address
Department of Cardiac Surgery, Shahid Chamran Hospital, Mushtaq Street
City
Isfahan
Province
Isfehan
Postal code
8158388997
Phone
+98 31 3260 0961
Email
ghasemi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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