Cardiac Surgery Associated - Acute Kidney InjurySCARS-AKINCT07370831
Incidence and Prognostic of Cardiac Surgery-Associated Acute Kidney Injury: A Spanish Multicenter Study (SCARS-AKI)
An observational study of Cardiac Surgery Associated - Acute Kidney Injury and CKD (Chronic Kidney Disease) Stage 5D, run by Universidad de Oviedo at 1 site in Spain.
Trial summary
To predict the renal damage caused by cardiac surgery in patients to try to mitigate it as soon as possible Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Surgery Associated - Acute Kidney Injury, CKD (Chronic Kidney Disease) Stage 5D, Acute Kidney Injury
- What is being tested?
- CARDIAC SURGERY
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 1 Sep 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients over 18 years old undergoing all types of major cardiac surgery
Who may be able to join
- All patients over 18 years of age undergoing cardiac surgery.
Who cannot join
- Exitus in the first 48h postoperative period
- Patient undergoing renal replacement therapy or preoperative dialysis
- Minor" cardiac surgery ( sternal dehiscence, MCP removal or implantation, pericardial window)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Validation Study of a Laboratory-based Perioperative Prediction Model for Acute Kidney Injury After Cardiac Surgery.
To predict the renal damage caused by cardiac surgery in patients to try to mitigate it as soon as possible
Read the detailed description
Acute Kidney Injury (AKI) is a major complication of cardiac surgery and its most severe forms are associated with significant morbidity and mortality .
Identification of patients at risk may facilitate early use of management protocoolos recommended by KDIGO (Kidney Disease: Improving Global Outcomes), such as haemodynamic and volume optimisation, monitoring of renal function and discontinuation or reduction of nephrotoxic drugs . The rate associated with cardiac surgery varies according to its different historical definitions, from 0.3% to 29.7% . Cases requiring renal replacement therapy (RRT) occur between 1 .2%-3.0% in the studied cardiac surgery cohorts and their presence is a n independent predictor of mortality.
Because AKI still lacks effective treatments in addition to support and elimination of the cause, early and specific diagnosis is an unmet but critical need f o r successful and personalised patient management.
Creatinine, urea and urine output have been and are the main ways to diagnose and treat renal failure. Other types of biomarkers that seem to be related to risk of postoperative AKI are currently under study. Although more research is needed, they may eventually become predictive diagnostic tools. Several studies have indicated that the urinary level of NGAL excreted intraoperatively and after surgery is effective in predicting AKI in both adult and paediatric populations. Similar results have been obtained with other urinary biomarkers, such as the cell cycle arrest biomarkers TIMP-2 and IGFBP7) KIM-1, NAG, IL-18 and L-FAP . The major limitation of these biomarkers is that they are not easily accessible in all hospitals and clinical settings. Recently Demirjian developed a predictive model in which they observed that perioperative change in serum creatinine and postoperative blood urea nitrogen, serum sodium, potassium, bicarbonate and albumin from the first metabolic panel after cardiac surgery show good predictive value for moderate to severe AKI within 72 hours and 14 days after the surgical procedure.
- Hypothesis
The score developed by Demirjian et al has a good predictive ability for moderate to severe AKI after cardiac surgery in the European population.
- Objectives
4.1 Main
- Confirm the usefulness and externally validate the scale.
- Compare this scale with other models of AKI prediction after cardiac surgery: Thakar, Mehta, ISR, Callejas, Leicester, CRATE.
4.2 Secondary
- Identify new risk factors for Acute Kidney Injury (AKI)
- Understanding the incidence of AKI after cardiac surgery in Europe
- Validating a model for predicting discharge dialysis after cardiac surgery
- Investigate the performance of these models in specific surgeries: coronary surgery without cardiopulmonary bypass and heart transplantation.
- Assess the performance of other scales and compare them.
- Determine the prevalence and risk factors for Acute Kidney Disease (AKD) (renal injury beyond 7 days, up to 90 days).
- Determine the prevalence and risk factors for new Chronic Kidney Disease (CKD) (follow-up for 120 days or 4 months).
- Determine the prevalence and risk factors for CKD progression, defined by a one-stage progression in patients with pre-existing CKD. Follow-up for 120 days (4 months).
- Conditions
- Cardiac Surgery Associated - Acute Kidney Injury, CKD (Chronic Kidney Disease) Stage 5D, Acute Kidney Injury, Acute Kidney Disease
- Being tested
- CARDIAC SURGERY
- Keywords
- CSA AKI, AKI
- Medical subject headings
- Renal Insufficiency, Chronic, 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
PATIENTS UNDERGOING CARDIAC SURGERY
What is being measured
The primary outcome is the main question the study is designed to answer.
- Confirm the usefulness and externally validate the Demijirian scale.
Validate scale
Measured: up to 14th postoperative day
- Compare this scale with other models of AKI prediction after cardiac surgery: Thakar, Mehta, ISR, Callejas, Leicester, CRATE.
Score validation
Measured: up to 14th postoperative day
Secondary outcomes (4)
- Identify new risk factors for Acute Kidney Injury (AKI)
AKI risk factor
Measured: from surgery to 4months postoperative
- Validating a model for predicting discharge dialysis after cardiac surgery
Develope a dialysis after cardiac surgery score
Measured: from surgery to 4monts postoperative
risk factors for new Chronic Kidney Disease (CKD)
Determine the prevalence and risk factors for new Chronic Kidney Disease (CKD) (follow-up for 120 days or 4 months).
Measured: from surgery to 4months postoperative
Drugs related with CSA AKI
Study relation of : ISGLP2, GLP2, IDPP4, Sacubitril/valsartan with CS AKI
Measured: from surgery to 4months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery Associated - Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 2,500 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universidad de Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Baeza Álvarez, Universidad de Oviedo
- Investigators
- Luis Baeza Alvarez, MD, Principal investigator, Universidad de OviedoMarc Vives Santacana, PhD, Study director, Clinica Universidad de NavarraPablo Avanzas Fernández, PhD, Study director, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370831
- Sponsor's protocol ID
- CEImPA 2023.111
- Acronym
- SCARS-AKI
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not necessary
Publications
Demirjian S, Bashour CA, Shaw A, Schold JD, Simon J, Anthony D, Soltesz E, Gadegbeku CA. Predictive Accuracy of a Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery. JAMA. 2022 Mar 8;327(10):956-964. doi: 10.1001/jama.2022.1751.
PubMed 35258532Mehta RH, Grab JD, O'Brien SM, Bridges CR, Gammie JS, Haan CK, Ferguson TB, Peterson ED; Society of Thoracic Surgeons National Cardiac Surgery Database Investigators. Bedside tool for predicting the risk of postoperative dialysis in patients undergoing cardiac surgery. Circulation. 2006 Nov 21;114(21):2208-16; quiz 2208. doi: 10.1161/CIRCULATIONAHA.106.635573. Epub 2006 Nov 6.
PubMed 17088458Lange HW, Aeppli DM, Brown DC. Survival of patients with acute renal failure requiring dialysis after open heart surgery: early prognostic indicators. Am Heart J. 1987 May;113(5):1138-43. doi: 10.1016/0002-8703(87)90925-2.
PubMed 3578008