NCT07343830

Brief Summary

Acute kidney injury (AKI) is a common and serious complication following cardiac surgery performed under cardiopulmonary bypass and is associated with increased morbidity, mortality, and prolonged hospital stay. Despite advances in perioperative management, the ability to accurately predict postoperative AKI remains limited. Recent evidence suggests that preoperative inflammatory markers derived from routine laboratory tests, as well as indicators of intraoperative perfusion stress, may play an important role in the development of AKI. However, data evaluating these factors together in patients undergoing cardiac surgery with cardiopulmonary bypass are limited. This retrospective observational cohort study aims to investigate the association between preoperative renal function, inflammatory indices, and intraoperative perfusion-related parameters with the development of postoperative AKI. Acute kidney injury will be defined according to the KDIGO serum creatinine criteria within the first 72 hours after surgery. The findings of this study may help identify patients at increased risk for AKI and contribute to improved perioperative risk stratification in cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

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

First Submitted

Initial submission to the registry

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2026

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3 days

First QC Date

January 6, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

Acute kidney injuryCardiac surgeryCardiopulmonary bypassInflammatory markersNeutrophil to lymphocyte ratioSystemic immune inflammation indexC-reactive protein albumin ratioRenal perfusionPerfusion stressKDIGO

Outcome Measures

Primary Outcomes (1)

  • Postoperative Acute Kidney Injury

    Development of acute kidney injury within 72 hours after cardiac surgery performed under cardiopulmonary bypass. Acute kidney injury will be defined according to the KDIGO serum creatinine criteria, based on an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days. Urine output criteria will not be evaluated due to the retrospective nature of the study.

    Within 72 hours after cardiac surgery

Secondary Outcomes (2)

  • Severity of postoperative AKI (KDIGO stage)

    Within 72 hours after cardiac surgery (postoperative days 0-3); assessed using the highest serum creatinine value measured every 12 hours (6 measurements)

  • In-Hospital Mortality

    From the date of cardiac surgery through hospital discharge (index hospitalization), assessed at hospital discharge (up to 90 days)

Study Arms (2)

Postoperative AKI

Patients who developed acute kidney injury within 72 hours after cardiac surgery under cardiopulmonary bypass, defined according to the KDIGO serum creatinine criteria.

No Postoperative AKI

Patients who did not develop acute kidney injury within 72 hours after cardiac surgery under cardiopulmonary bypass according to the KDIGO serum creatinine criteria.

Eligibility Criteria

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

Adult patients undergoing cardiac surgery with cardiopulmonary bypass at a single tertiary care center.

You may qualify if:

  • Adults aged 18 years or older
  • Patients who underwent cardiac surgery under cardiopulmonary bypass
  • Coronary artery bypass grafting, valve surgery, or combined cardiac surgery
  • Elective or emergency procedures

You may not qualify if:

  • Preoperative end-stage renal disease requiring dialysis
  • Preoperative serum creatinine level greater than 4.0 mg/dL
  • Off-pump cardiac surgery
  • Missing preoperative or postoperative serum creatinine data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (8)

  • Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

    PMID: 22890468BACKGROUND
  • Lee JW, Sharma AR, Lee SS, Chun WJ, Kim HS. The C-reactive protein to albumin ratio predicts postoperative complication in patients who undergo gastrectomy for gastric cancer. Heliyon. 2020 Jun 15;6(6):e04220. doi: 10.1016/j.heliyon.2020.e04220. eCollection 2020 Jun.

    PMID: 32577578BACKGROUND
  • Sun J, Qi Y, Wang W, Meng P, Han C, Chen B. Systemic Immune-Inflammation Index (SII) as a Predictor of Short-Term Mortality Risk in Sepsis-Associated Acute Kidney Injury: A Retrospective Cohort Study. Med Sci Monit. 2024 Jun 28;30:e943414. doi: 10.12659/MSM.943414.

    PMID: 38937949BACKGROUND
  • Bi JB, Zhang J, Ren YF, Du ZQ, Wu Z, Lv Y, Wu RQ. Neutrophil-to-lymphocyte ratio predicts acute kidney injury occurrence after gastrointestinal and hepatobiliary surgery. World J Gastrointest Surg. 2020 Jul 27;12(7):326-335. doi: 10.4240/wjgs.v12.i7.326.

    PMID: 32821341BACKGROUND
  • Huen SC, Parikh CR. Predicting acute kidney injury after cardiac surgery: a systematic review. Ann Thorac Surg. 2012 Jan;93(1):337-47. doi: 10.1016/j.athoracsur.2011.09.010.

    PMID: 22186469BACKGROUND
  • Lannemyr L, Bragadottir G, Hjarpe A, Redfors B, Ricksten SE. Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation in Patients Undergoing Cardiac Operations. Ann Thorac Surg. 2019 Feb;107(2):505-511. doi: 10.1016/j.athoracsur.2018.08.085. Epub 2018 Oct 23.

    PMID: 30365961BACKGROUND
  • Lagny MG, Jouret F, Koch JN, Blaffart F, Donneau AF, Albert A, Roediger L, Krzesinski JM, Defraigne JO. Incidence and outcomes of acute kidney injury after cardiac surgery using either criteria of the RIFLE classification. BMC Nephrol. 2015 May 30;16:76. doi: 10.1186/s12882-015-0066-9.

    PMID: 26025079BACKGROUND
  • Hobson CE, Yavas S, Segal MS, Schold JD, Tribble CG, Layon AJ, Bihorac A. Acute kidney injury is associated with increased long-term mortality after cardiothoracic surgery. Circulation. 2009 May 12;119(18):2444-53. doi: 10.1161/CIRCULATIONAHA.108.800011. Epub 2009 Apr 27.

    PMID: 19398670BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

January 30, 2026

Primary Completion

February 2, 2026

Study Completion

February 2, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the retrospective nature of the study and institutional data protection and patient confidentiality regulations. Only de-identified aggregate data will be reported in publications.

Locations