Acute Kidney Injury After Cardiac Surgery

NCT05079724 | Unknown

• 1 other identifier: AKIN and Cardiac Surgery
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to identify the Following: -

1. 1.incidence and mortality of cardiac Surgery associated -AKI based on the new consensus diagnostic systems of KDIGO (Kidney Disease Improving Global Outcomes).
2. 2.use of biomarkers for the early detection of clinical and subclinical cardiac Surgery associated-AKI.
3. 3.risk factors and prediction models of cardiac Surgery associated-AKI.
4. 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. 5.controversial pharmacologic therapies for the prevention and treatment of cardiac Surgery associated-AKI including statins, sodium bicarbonate, and N-acetylcysteine (NAC).

Conditions

Heart Diseases; Heart Valve Diseases; Heart Shock; Cardiac Disease; Cardio-Renal Syndrome; Cardio Respiratory Arrest; Cardiopulmonary Disease; Cardiopulmonary Arrest With Successful Resuscitation; Cardio-pulmonary Bypass; Cardiothoracic Surgery; Acute Kidney Injury; Acute Kidney Injury Due to Circulatory Failure; Coronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• ICU and hospital Length of stay

  Baseline

• Vent days

  Baseline

• The need for renal replacement therapy

  Baseline

• Renal recovery

  Baseline

Interventions

Cardiac Surgery PROCEDURE

About 3.5-31.0% of Patients undergoing cardiac surgery Complains from Postoperative Acute renal injury (AKI) that is a severe complication increasing the risk factor for mortality about 8-folds, The occurrence of AKI in patients undergoing cardiac surgery raises the mortality rate from 0.4-4.4% to 1.3-22.3%; when those same patients require dialysis.

Also known as: Renal dialysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients between 18 and 80 years of age who will undergo cardiac surgery, between 2021 and 2024, except those mentioned in exclusion criteria. All the procedures will be performed at a tertiary care cardiac hospital that serves the public and private sector.

You may qualify if:

• On-pump cardiac surgery;
• Off-pump Cardiac Surgery;
• Affiliated patient or beneficiary of a social protection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (14)

• 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.

  PMID: 27982349 BACKGROUND

• Mehta RL. Acute renal failure and cardiac surgery: marching in place or moving ahead? J Am Soc Nephrol. 2005 Jan;16(1):12-4. doi: 10.1681/ASN.2004110954. Epub 2004 Dec 8. No abstract available.

  PMID: 15590755 BACKGROUND

• 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. doi: 10.1161/01.cir.95.4.878.

  PMID: 9054745 BACKGROUND

• 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.

  PMID: 29267610 BACKGROUND

• 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.

  PMID: 28700753 BACKGROUND

• Ortega-Loubon C, Fernandez-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.

  PMID: 27716701 BACKGROUND

• 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. doi: 10.1590/s0066-782x2004001400006. Epub 2004 Aug 17. English, Portuguese.

  PMID: 15322657 BACKGROUND

• 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.

  PMID: 29268379 BACKGROUND

• 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. doi: 10.1590/s0102-76382007000400016. English, Portuguese.

  PMID: 18488117 BACKGROUND

• Andersson LG, Ekroth R, Bratteby LE, Hallhagen S, Wesslen 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. doi: 10.1055/s-2007-1013861.

  PMID: 8211928 BACKGROUND

• 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.

  PMID: 20172909 BACKGROUND

• 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. doi: 10.5935/0103-507x.20140027.

  PMID: 25028954 BACKGROUND

• 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. No abstract available.

  PMID: 22890468 BACKGROUND

• 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.

  PMID: 25005361 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Heart Valve Diseases; Shock, Cardiogenic; Cardio-Renal Syndrome; Heart Arrest; Pulmonary Heart Disease; Acute Kidney Injury

Interventions

Cardiac Surgical Procedures; Renal Dialysis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Omar A Sadek, M.Sc.

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar A Sadek, M.Sc.

CONTACT

+201013141529; arafats_omar@yahoo.com

Mohamed A Khalil Salama Ayyad, Professor

CONTACT

+201002001932; makayyad@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 15, 2021
• Study Start: November 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 19, 2021

Record last verified: 2021-10