To find the KDIGO guidelines effects in Cardiac surgery patients, prone to Acute Kidney Injury.
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Study was conducted at Afridi medical complex, Peshawar. The outcome assessor was blinded in the study.
Participants/Inclusion and exclusion criteria
Inclusion: Age 50-80 years with both gender. Participants who maintain central venous pressure (CVP) between 8 and 10 mmHg and mean arterial pressure (MAP) >65 mmHg.
Exclusion: Patients with end-stage renal disease on dialysis, recent kidney transplantation and
contraindications for participation (e.g., pregnancy, severe comorbidities).
Intervention groups
Experimental group: Patients in the intervention group underwent a rigorously controlled administration of the KDIGO recommendations (the "KDIGO CT surgery bundle"), which included the consequent actions: avoiding nephrotoxic substances, stopping angiotensin II receptor blockers (ARBs) and angiotensin converting enzyme inhibitors (ACEi) for the first fourty eight hours following operation.
Control Group: The standard of treatment for persons in the control group included instructions to maintain central venous pressure (CVP) between 8 and 10 mmHg and mean arterial pressure (MAP) >65 mmHg. As soon as the hemodynamic status stabilized and hypertension appeared, patients were given angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARBs).
Main outcome variables
The incidence of AKI within the first 72 hours following heart surgery served as the main variable.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230907059376N6
Registration date:2024-10-02, 1403/07/11
Registration timing:retrospective
Last update:2024-10-02, 1403/07/11
Update count:0
Registration date
2024-10-02, 1403/07/11
Registrant information
Name
Sarmad Khattak
Name of organization / entity
Rehman Medical Institute, Peshawar
Country
Pakistan
Phone
+92 91 5838666
Email address
sarmadkhattak007@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-27, 1400/12/08
Expected recruitment end date
2023-02-21, 1401/12/02
Actual recruitment start date
2022-02-24, 1400/12/05
Actual recruitment end date
2023-03-23, 1402/01/03
Trial completion date
2023-03-27, 1402/01/07
Scientific title
KDIGO guidelines effects in Cardiac surgery patients, prone to Acute Kidney Injury
Public title
KDIGO guidelines effects in Cardiac surgery patients, prone to Acute Kidney Injury. A Randomized Control Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Maintain central venous pressure (CVP) between 8 and 10 mmHg
Mean arterial pressure (MAP) >65 mmHg
Exclusion criteria:
Hyperglycemia
Urinary [TIMP-2].[IGFBP7] ≥ 0.3
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
86
Actual sample size reached:
86
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process for the study will utilize simple randomization through a computer-generated random number sequence, ensuring that each participant has an equal chance of being assigned to either the intervention group (KDIGO guidelines) or the control group (standard care). The unit of randomization will be the individual participant, allowing for direct comparisons of outcomes between the two groups. While stratified randomization is not planned, if it were implemented, it would involve defining strata based on key variables such as age or baseline renal function to ensure balanced representation. The randomization will be facilitated by secure computer software that generates the random sequence, which will be prepared before participant recruitment begins to eliminate any potential biases. To maintain allocation concealment, sealed opaque envelopes containing the group assignments will be used; these will only be opened after a participant has been enrolled and consented. This rigorous approach to randomization aims to enhance the integrity of the study, ultimately providing reliable results on the effects of KDIGO guidelines on Acute Kidney Injury in cardiac surgery patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, assessors will be blinded to participants' group allocations to minimize bias in outcome evaluation. A separate third-party team will collect and analyze data, ensuring that assessors remain unaware of whether participants are in the intervention or control group. All outcome measurements will be coded, preventing any influence on their evaluations. This double-blind approach aims to enhance the validity of the findings regarding the impact of KDIGO guidelines on Acute Kidney Injury in cardiac surgery patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Afridi Medical Complex ethical committee
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25150
Approval date
2022-02-01, 1400/11/12
Ethics committee reference number
AMC/REC/2022/12
Health conditions studied
1
Description of health condition studied
Acute kidney disease
ICD-10 code
N17
ICD-10 code description
Acute kidney failure
Primary outcomes
1
Description
The incidence of Acute kidney injury within the first 72 hours following heart surgery served as the main objective.
Timepoint
The degree of acute kidney inury within seventy two hours, the thirty, sixty, and ninty days.
Method of measurement
KDIGO standards
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group underwent a rigorously controlled administration of the KDIGO recommendations (the "KDIGO CT surgery bundle"), which included the consequent actions: avoiding nephrotoxic substances, stopping angiotensin II receptor blockers (ARBs) and angiotensin converting enzyme inhibitors (ACEi) for the first fourty eight hours following operation, closely recording urine output and serum creatinine , avoiding hyperglycemia for the first seventy two hours postoperatively, considering substitutes to radiocontrast substances, and closely observing hemodynamics.
Category
Treatment - Drugs
2
Description
Control group: The standard of treatment for persons in the control group included instructions to maintain central venous pressure (CVP) between 8 and 10 mmHg and mean arterial pressure (MAP) >65 mmHg. As soon as the hemodynamic status stabilized and hypertension appeared, patients were given angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARBs).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afridi Medical Complex, Peshawar
Full name of responsible person
Mehboob Khan
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25150
Phone
+92 91 5711751
Email
mehbob509@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Afridi Medical Complex, Peshawar
Full name of responsible person
Mahboob Khan
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25150
Phone
+92 91 5711751
Email
mehboob509@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Afridi Medical Complex, Peshawar
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Afridi Medical Complex, Peshawar
Full name of responsible person
Mahboob Khan
Position
Consultant Neurosurgeon
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25150
Phone
+92 91 5711751
Email
mehboob509@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Afridi Medical Complex, Peshawar
Full name of responsible person
Mahboob Khan
Position
Consultant Neurosurgeon
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25150
Phone
+92 91 5711751
Email
mehboob509@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Afridi Medical Complex, Peshawar
Full name of responsible person
Mahboob Khan
Position
Consultant Neurosurgeon
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25150
Phone
+92 91 5711751
Email
mehboob509@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
KDIGO guidelines effects in Cardiac surgery patients, prone to Acute Kidney Injury. A Randomized Control Trial
When the data will become available and for how long
Data will be available after 6 months of publication for 1 year.
To whom data/document is available
The data will be available to all the doctors.
Under which criteria data/document could be used
Data will be used just for education.
From where data/document is obtainable
Data will be obtained from corresponding author mentioned in journal after publication.
What processes are involved for a request to access data/document
Person should email the corresponding author and wait for response in one week.