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IRCT20230907059376N6 IRCT 2024-10-02 Afridi Medical Complex, Peshawar KDIGO guidelines effects in Cardiac surgery patients, prone to Acute Kidney Injury. A Randomized Control Trial KDIGO guidelines effects in Cardiac surgery patients, prone to Acute Kidney Injury 2022-02-27 anticipated 86 Complete https://irct.ir/trial/79243 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Acute kidney disease. Intervention 1: 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. Intervention 2: 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). Yes - There is a plan to make this available What will be shared: KDIGO guidelines effects in Cardiac surgery patients, prone to Acute Kidney Injury. A Randomized Control Trial When: Data will be available after 6 months of publication for 1 year. To whom: The data will be available to all the doctors. Conditions: Data will be used just for education. Where to obtain: Data will be obtained from corresponding author mentioned in journal after publication. How to obtain: Person should email the corresponding author and wait for response in one week. Comments:
public Mahboob Khan
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25150 +92 91 5711751 mehboob509@gmail.com Afridi Medical Complex, Peshawar scientific Mahboob Khan
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25150 +92 91 5711751 mehboob509@gmail.com Afridi Medical Complex, Peshawar Pakistan Maintain central venous pressure (CVP) between 8 and 10 mmHg Mean arterial pressure (MAP) >65 mmHg 50 years 80 years Both Hyperglycemia Urinary [TIMP-2].[IGFBP7] ≥ 0.3 N17 Acute kidney failure Treatment - Drugs Treatment - Drugs 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. 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). 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. Afridi Medical Complex, Peshawar Approved 2022-02-01 Afridi Medical Complex ethical committee Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa Peshawar KhyberPakhtunkhwa Pakistan