NCT07370831

Brief Summary

To predict the renal damage caused by cardiac surgery in patients to try to mitigate it as soon as possible

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 12, 2026

Last Update Submit

January 21, 2026

Conditions

CKD (Chronic Kidney Disease) Stage 5DAcute Kidney InjuryAcute Kidney DiseaseCardiac Surgery Associated - Acute Kidney Injury

Keywords

CSA AKIAKI

Outcome Measures

Primary Outcomes (2)

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

    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.

    Score validation

    up to 14th postoperative day

Secondary Outcomes (4)

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

    from surgery to 4months postoperative

  • - Validating a model for predicting discharge dialysis after cardiac surgery

    from surgery to 4monts postoperative

  • risk factors for new Chronic Kidney Disease (CKD)

    from surgery to 4months postoperative

  • Drugs related with CSA AKI

    from surgery to 4months postoperative

Interventions

CARDIAC SURGERYPROCEDURE

PATIENTS UNDERGOING CARDIAC SURGERY

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUCA

Oviedo, Principality of Asturias, 33011, Spain

Location

Related Publications (3)

  • 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.

    PMID: 35258532RESULT

  • 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.

    PMID: 17088458RESULT

  • 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.

    PMID: 3578008RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicAcute Kidney Injury

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Luis Baeza Alvarez, MD

    Universidad de Oviedo

    PRINCIPAL INVESTIGATOR

  • Marc Vives Santacana, PhD

    Clinica Universidad de Navarra

    STUDY DIRECTOR

  • Pablo Avanzas Fernández, PhD

    Universidad de Oviedo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 27, 2026

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Not necessary

Locations

ES(1)