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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
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 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.

Spain1 site

  • HUCA

    Oviedo, Principality of Asturias, 33011

Other trials in Spain

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.

  1. 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.

  1. 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).
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.

  1. - Confirm the usefulness and externally validate the Demijirian scale.

    Validate scale

    Measured: up to 14th postoperative day

  2. - 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)

  1. - Identify new risk factors for Acute Kidney Injury (AKI)

    AKI risk factor

    Measured: from surgery to 4months postoperative

  2. - Validating a model for predicting discharge dialysis after cardiac surgery

    Develope a dialysis after cardiac surgery score

    Measured: from surgery to 4monts postoperative

  3. 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

  4. 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.

  1. First posted27 Jan 2026
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Sep 2024

Resources

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
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 35258532

  • Mehta 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 17088458

  • Lange 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

Questions about this trial

What is this clinical trial studying?

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.

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 1 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

- Confirm the usefulness and externally validate the Demijirian scale. (time frame: up to 14th postoperative day). The study lists 2 primary outcomes in all. 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 NCT07370831, which also lists 3 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 27 Jan 2026.

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