Incidence and Prognostic of Cardiac Surgery-Associated Acute Kidney Injury: A Spanish Multicenter Study (SCARS-AKI) (SCARS-AKI)

January 21, 2026 updated by: Luis Baeza Álvarez, Universidad de Oviedo

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

3. 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.

4. 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).

Study Type

Observational

Enrollment (Actual)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • HUCA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients over 18 years old undergoing all types of major cardiac surgery

Description

Inclusion Criteria:

  • All patients over 18 years of age undergoing cardiac surgery.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Confirm the usefulness and externally validate the Demijirian scale.
Time Frame: up to 14th postoperative day
Validate scale
up to 14th postoperative day
- Compare this scale with other models of AKI prediction after cardiac surgery: Thakar, Mehta, ISR, Callejas, Leicester, CRATE.
Time Frame: up to 14th postoperative day
Score validation
up to 14th postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Identify new risk factors for Acute Kidney Injury (AKI)
Time Frame: from surgery to 4months postoperative
AKI risk factor
from surgery to 4months postoperative
- Validating a model for predicting discharge dialysis after cardiac surgery
Time Frame: from surgery to 4monts postoperative
Develope a dialysis after cardiac surgery score
from surgery to 4monts postoperative
risk factors for new Chronic Kidney Disease (CKD)
Time Frame: from surgery to 4months postoperative
Determine the prevalence and risk factors for new Chronic Kidney Disease (CKD) (follow-up for 120 days or 4 months).
from surgery to 4months postoperative
Drugs related with CSA AKI
Time Frame: from surgery to 4months postoperative
Study relation of : ISGLP2, GLP2, IDPP4, Sacubitril/valsartan with CS AKI
from surgery to 4months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Oviedo

Investigators

  • Principal Investigator: Luis Baeza Alvarez, MD, Universidad de Oviedo
  • Study Director: Marc Vives Santacana, PhD, Clinica Universidad de Navarra
  • Study Director: Pablo Avanzas Fernández, PhD, Universidad de Oviedo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEImPA 2023.111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not necessary

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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