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To predict the renal damage caused by cardiac surgery in patients to try to mitigate it as soon as possible
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
4.2 Secondary
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARDIAC SURGERY | Procedure | PATIENTS UNDERGOING CARDIAC SURGERY |
| Measure | Description | Time Frame |
|---|---|---|
| - 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 |
| Measure | Description | Time Frame |
|---|---|---|
| - Identify new risk factors for Acute Kidney Injury (AKI) | AKI risk factor | from surgery to 4months postoperative |
| - Validating a model for predicting discharge dialysis after cardiac surgery | Develope a dialysis after cardiac surgery score |
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Inclusion Criteria:
Exclusion Criteria:
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All patients over 18 years old undergoing all types of major cardiac surgery
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUCA | Oviedo | Principality of Asturias | 33011 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35258532 | Result | 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. | |
| 17088458 | Result |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2023 |
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| 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). | from surgery to 4months postoperative |
| Drugs related with CSA AKI | Study relation of : ISGLP2, GLP2, IDPP4, Sacubitril/valsartan with CS AKI | from surgery to 4months postoperative |
| 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. |
| 3578008 | Result | 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. |
| Jan 12, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| ID | Term |
|---|---|
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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