Heart Diseases Clinical Trial
Official title:
Acute Kidney Injury After Cardiac Surgery in Patients Without Chronic Kidney Disease.
The study aims to identify the Following: - 1. incidence and mortality of cardiac Surgery associated -AKI based on the new consensus diagnostic systems of KDIGO (Kidney Disease Improving Global Outcomes). 2. use of biomarkers for the early detection of clinical and subclinical cardiac Surgery associated-AKI. 3. risk factors and prediction models of cardiac Surgery associated-AKI. 4. optimal cardiac surgical procedures including conventional versus minimally invasive approaches, on-pump versus off-pump, and optimal management of cardiac surgical support including duration of CPB, perfusion pressure, hemodilution, and hypothermia during CPB. 5. controversial pharmacologic therapies for the prevention and treatment of cardiac Surgery associated-AKI including statins, sodium bicarbonate, and N-acetylcysteine (NAC).
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | November 1, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - On-pump cardiac surgery; - Off-pump Cardiac Surgery; - Informed and written consent of the patient or inclusion according to the emergency procedure; - Affiliated patient or beneficiary of a social protection. Exclusion Criteria: - Patients who underwent cardiac surgery for congenital heart disease. - Patients who underwent emergency heart surgery. - patients who, within the last 72 hours before surgery, were injected with iodinated contrast (because of its potential nephrotoxicity). - patients with chronic Kidney disease. 5- patients with a preoperative serum creatinine >2 mg/dL. - patients who died within the first 24 hours after surgery. - patients on mechanical ventilation before intervention. - Patients with preoperative medical disorders other than cardiac affection. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Andersson LG, Ekroth R, Bratteby LE, Hallhagen S, Wesslén O. Acute renal failure after coronary surgery--a study of incidence and risk factors in 2009 consecutive patients. Thorac Cardiovasc Surg. 1993 Aug;41(4):237-41. — View Citation
Chertow GM, Lazarus JM, Christiansen CL, Cook EF, Hammermeister KE, Grover F, Daley J. Preoperative renal risk stratification. Circulation. 1997 Feb 18;95(4):878-84. — View Citation
De Santo LS, Romano G, Mango E, Iorio F, Savarese L, Numis F, Zebele C. Age and blood transfusion: relationship and prognostic implications in cardiac surgery. J Thorac Dis. 2017 Oct;9(10):3719-3727. doi: 10.21037/jtd.2017.08.126. — View Citation
Ferreiro A, Lombardi R. Acute kidney injury after cardiac surgery is associated with mid-term but not long-term mortality: A cohort-based study. PLoS One. 2017 Jul 10;12(7):e0181158. doi: 10.1371/journal.pone.0181158. eCollection 2017. — View Citation
Fortes JV, Barbosa e Silva MG, Baldez TE, Costa MA, da Silva LN, Pinheiro RS, Fecks ZS, Borges DL. Mortality Risk After Cardiac Surgery: Application of Inscor in a University Hospital in Brazil's Northeast. Braz J Cardiovasc Surg. 2016 Sep-Oct;31(5):396-399. doi: 10.5935/1678-9741.20160080. — View Citation
Jiang W, Xu J, Shen B, Wang C, Teng J, Ding X. Validation of Four Prediction Scores for Cardiac Surgery-Associated Acute Kidney Injury in Chinese Patients. Braz J Cardiovasc Surg. 2017 Nov-Dec;32(6):481-486. doi: 10.21470/1678-9741-2017-0116. — View Citation
Jyrala A, Weiss RE, Jeffries RA, Kay GL. Effect of mild renal dysfunction (s-crea 1.2-2.2 mg/dl) on presentation characteristics and short- and long-term outcomes of on-pump cardiac surgery patients. Interact Cardiovasc Thorac Surg. 2010 May;10(5):777-82. doi: 10.1510/icvts.2009.231068. Epub 2010 Feb 19. — View Citation
Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. — View Citation
Luo X, Jiang L, Du B, Wen Y, Wang M, Xi X; Beijing Acute Kidney Injury Trial (BAKIT) workgroup. A comparison of different diagnostic criteria of acute kidney injury in critically ill patients. Crit Care. 2014 Jul 8;18(4):R144. doi: 10.1186/cc13977. — View Citation
Mehta RL. Acute renal failure and cardiac surgery: marching in place or moving ahead? J Am Soc Nephrol. 2005 Jan;16(1):12-4. Epub 2004 Dec 8. Review. — View Citation
Ortega-Loubon C, Fernández-Molina M, Carrascal-Hinojal Y, Fulquet-Carreras E. Cardiac surgery-associated acute kidney injury. Ann Card Anaesth. 2016 Oct-Dec;19(4):687-698. doi: 10.4103/0971-9784.191578. Review. — View Citation
Pontes JC, Silva GV, Benfatti RA, Machado NP, Pontelli R, Pontes ER. Risk factors for the development of acute renal failure following on-pump coronary artery bypass grafting. Rev Bras Cir Cardiovasc. 2007 Oct-Dec;22(4):484-90. English, Portuguese. — View Citation
Santana-Santos E, Marcusso ME, Rodrigues AO, Queiroz FG, Oliveira LB, Rodrigues AR, Palomo Jda S. [Strategies for prevention of acute kidney injury in cardiac surgery: an integrative review]. Rev Bras Ter Intensiva. 2014 Apr-Jun;26(2):183-92. Review. Portuguese. — View Citation
Santos FO, Silveira MA, Maia RB, Monteiro MD, Martinelli R. Acute renal failure after coronary artery bypass surgery with extracorporeal circulation -- incidence, risk factors, and mortality. Arq Bras Cardiol. 2004 Aug;83(2):150-4; 145-9. Epub 2004 Aug 17. English, Portuguese. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The early identification of patients at risk of developing AKI after cardiac surgery | observing if The early identification of patients at risk of developing AKI after cardiac surgery will or will not affect the postoperative Mortality. | Baseline | |
Secondary | ICU and hospital Length of stay | observing if the patients which will develop AKI after cardiac surgery will or will not affect their ICU and hospital Length of stay. | Baseline | |
Secondary | Vent days | observing if the patients which will develop AKI after cardiac surgery will or will not affect their need for and the Period of Mechanical ventilation. | Baseline | |
Secondary | The need for renal replacement therapy | observing if the patients which will develop AKI after cardiac surgery will or will not become in need for renal replacement therapy. | Baseline | |
Secondary | Renal recovery | observing the relation between developing AKI after cardiac surgery and Renal recovery. | Baseline |
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