Heart DiseasesNCT05079724
Acute Kidney Injury After Cardiac Surgery
An observational study of Heart Diseases and Heart Valve Diseases, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Diseases, Heart Valve Diseases, Heart Shock
- What is being tested?
- Cardiac Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Acute Kidney Injury After Cardiac Surgery in Patients Without Chronic Kidney Disease.
The study aims to identify the Following: -
- incidence and mortality of cardiac Surgery associated -AKI based on the new consensus diagnostic systems of KDIGO (Kidney Disease Improving Global Outcomes).
- use of biomarkers for the early detection of clinical and subclinical cardiac Surgery associated-AKI.
- risk factors and prediction models of cardiac Surgery associated-AKI.
- 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.
- controversial pharmacologic therapies for the prevention and treatment of cardiac Surgery associated-AKI including statins, sodium bicarbonate, and N-acetylcysteine (NAC).
Read the detailed description
Acute renal injury (AKI) is a severe complication that occurs in 3.5-31.0% of patients undergoing cardiac surgery, making it one of the most common complications observed in this group of patients.
Evidence suggests that even slight postoperative increases in serum creatinine levels are associated with a significant increase in the risk of death. Among individuals undergoing cardiac surgery, mortality has been reported to be as high as 8% and postoperative AKI can increase the mortality rate to over 60%. 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, rates range from 25% to 88.9%, making severe postoperative AKI an independent risk factor for mortality that results in an 8-fold increase in the risk of death. Therefore, cardiac surgery AKI is associated with serious complications as well as with prolonged intensive care unit (ICU) stays and with a worse quality of life. It also increases early and late mortality and health care expenditures.
The early identification of patients at risk of developing AKI after cardiac surgery is an important strategy for improving the care of such patients during the intraoperative and postoperative periods. Many factors have been found to facilitate the development of AKI after cardiac surgery such as: age; obesity; female gender; valve replacement surgery; myocardial infarction in the last 30 days; low cardiac output; blood transfusion; and many others.
Epidemiological studies of AKI in cardiac surgery patients are important because they allow for better diagnosis of AKI and facilitate the prognosis estimation, as well as the development of new, more effective strategies to prevent and minimize this complication, thus reducing the associated morbidity and mortality.
- Conditions
- Heart Diseases, Heart Valve Diseases, Heart Shock, Cardiac Disease, Cardio-Renal Syndrome, Cardio Respiratory Arrest
- Being tested
- Cardiac Surgery
- Medical subject headings
- Heart Diseases, Heart Valve Diseases, Shock, Cardiogenic, Cardio-Renal Syndrome, Heart Arrest, Pulmonary Heart Disease, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SurgeryProcedure or surgery
Also called Renal dialysis
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Renal recovery
observing the relation between developing AKI after cardiac surgery and Renal recovery.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Arafat Sadek Sayed, Assiut University
- Investigators
- Omar A Sadek, M.Sc., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079724
- Sponsor's protocol ID
- AKIN and Cardiac Surgery
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27982349Mehta 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.
PubMed 15590755Chertow 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.
PubMed 9054745Jiang 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.
PubMed 29267610Ferreiro 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.
PubMed 28700753Ortega-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.
PubMed 27716701Santos 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.
PubMed 15322657De 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.
PubMed 29268379Pontes 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.
PubMed 18488117Andersson 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.
PubMed 8211928Jyrala 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.
PubMed 20172909Santana-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.
PubMed 25028954Khwaja 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.
PubMed 22890468Luo 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.
PubMed 25005361
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury After Cardiac Surgery in Patients Without Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT05079724
- Acronym / sponsor ID
- AKIN and Cardiac Surgery
- Conditions
- Heart Diseases, Heart Valve Diseases, Heart Shock, Cardiac Disease, Cardio-Renal Syndrome, Cardio Respiratory Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to identify the Following: -
- incidence and mortality of cardiac Surgery associated -AKI based on the new consensus diagnostic systems of KDIGO (Kidney Disease Improving Global Outcomes).
- use of biomarkers for the early detection of clinical and subclinical cardiac Surgery associated-AKI.
- risk factors and prediction models of cardiac Surgery associated-AKI.
- 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.
- controversial pharmacologic therapies for the prevention and treatment of cardiac Surgery associated-AKI including statins, sodium bicarbonate, and N-acetylcysteine (NAC).
Detailed description
Acute renal injury (AKI) is a severe complication that occurs in 3.5-31.0% of patients undergoing cardiac surgery, making it one of the most common complications observed in this group of patients.
Evidence suggests that even slight postoperative increases in serum creatinine levels are associated with a significant increase in the risk of death. Among individuals undergoing cardiac surgery, mortality has been reported to be as high as 8% and postoperative AKI can increase the mortality rate to over 60%. 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, rates range from 25% to 88.9%, making severe postoperative AKI an independent risk factor for mortality that results in an 8-fold increase in the risk of death. Therefore, cardiac surgery AKI is associated with serious complications as well as with prolonged intensive care unit (ICU) stays and with a worse quality of life. It also increases early and late mortality and health care expenditures.
The early identification of patients at risk of developing AKI after cardiac surgery is an important strategy for improving the care of such patients during the intraoperative and postoperative periods. Many factors have been found to facilitate the development of AKI after cardiac surgery such as: age; obesity; female gender; valve replacement surgery; myocardial infarction in the last 30 days; low cardiac output; blood transfusion; and many others.
Epidemiological studies of AKI in cardiac surgery patients are important because they allow for better diagnosis of AKI and facilitate the prognosis estimation, as well as the development of new, more effective strategies to prevent and minimize this complication, thus reducing the associated morbidity and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac SurgeryAlso: Renal dialysisAbout 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. | Procedure or surgery | – |
Primary outcome
The early identification of patients at risk of developing AKI after cardiac surgery
Time frame: Baseline
observing if The early identification of patients at risk of developing AKI after cardiac surgery will or will not affect the postoperative Mortality.
4 secondary outcomes
ICU and hospital Length of stay
Time frame: Baseline
Vent days
Time frame: Baseline
The need for renal replacement therapy
Time frame: Baseline
Renal recovery
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Background: PubMed 27982349Fortes 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.
- Background: PubMed 15590755Mehta 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.
- Background: PubMed 9054745Chertow 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.
- Background: PubMed 29267610Jiang 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.
- Background: PubMed 28700753Ferreiro 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.
- Background: PubMed 27716701Ortega-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.
- Background: PubMed 15322657Santos 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.
- Background: PubMed 29268379De 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.
- Background: PubMed 18488117Pontes 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.
- Background: PubMed 8211928Andersson 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.
- Background: PubMed 20172909Jyrala 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.
- Background: PubMed 25028954Santana-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar A Sadek, M.Sc. principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Heart Valve Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar A Sadek, M.Sc. (+201013141529, arafats_omar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The early identification of patients at risk of developing AKI after cardiac surgery (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079724, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.