New Methods for Early Detection of Acute Kidney Injury After Heart Surgery

NCT03974347 | Withdrawn

• 1 other identifier: 2019-02319
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators intend to study 2 new methods for the early detection of Acute Kidney Injury (AKI) after cardiac surgery and compare and combine the predictive abilities of these methods with established renal injury markers and epidemiological models to detect (AKI).

Conditions

Acute Kidney Injury

Keywords

cardiac surgery; renal resistive index; creatinine clearance

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

  Acute Kidney Injury defined by KDiGO criteria

  48 hours

Secondary Outcomes (1)

• 30 day Mortality

  30 days

Study Arms (2)

Acute kidney injury, no acute kidney injury

Acute kidney injury after cardiac surgery will be defined by KDIGO criteria, Creatinine rise from baseline and or urine production.

No Acute Kidney Injury

No Acute kidney Injury after Cardiac surgery, according to KDIGO AKI definition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elective cardiac surgery patients undergoing surgery at Karolinska University Hospital, Sweden. Patients with high risk for AKI as identified by the Clevland Clinic acute renal failure score will be identified.

You may qualify if:

• years and older
• Undergoing elective cardiac surgery (Coronary artery bypass grafting, valve surgery, aortic surgery or a combination).
• Able to understand and give written consent to partake in the study

You may not qualify if:

• Unable to give consent
• Previously received a renal transplant
• Renal failure requiring dialysis prior to surgery
• Persistent atrial fibrillation

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (5)

• 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: 22890468 BACKGROUND

• Le Dorze M, Bougle A, Deruddre S, Duranteau J. Renal Doppler ultrasound: a new tool to assess renal perfusion in critical illness. Shock. 2012 Apr;37(4):360-5. doi: 10.1097/SHK.0b013e3182467156.

  PMID: 22258233 BACKGROUND

• Ryden L, Ahnve S, Bell M, Hammar N, Ivert T, Sartipy U, Holzmann MJ. Acute kidney injury after coronary artery bypass grafting and long-term risk of myocardial infarction and death. Int J Cardiol. 2014 Mar 1;172(1):190-5. doi: 10.1016/j.ijcard.2014.01.013. Epub 2014 Jan 22.

  PMID: 24502882 BACKGROUND

• Hertzberg D, Ceder SL, Sartipy U, Lund K, Holzmann MJ. Preoperative Renal Resistive Index Predicts Risk of Acute Kidney Injury in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Jun;31(3):847-852. doi: 10.1053/j.jvca.2016.10.006. Epub 2016 Oct 11.

  PMID: 28017677 BACKGROUND

• Ryden LC, Sartipy U, Holzmann MJ. Acute Kidney Injury After Surgical AVR and Long-Term Risk of Death and End-Stage Renal Disease. J Am Coll Cardiol. 2015 Nov 17;66(20):2263-2264. doi: 10.1016/j.jacc.2015.08.883. No abstract available.

  PMID: 26553408 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and Urine samples will be obtained. The following biomarkers will be measured NGAL, TIMP-2, IGFBP7, KIM-1, IL-18, L-FABP, cystatin C och angiotensinogen. Renal function markers Creatinine and urea will also be measured.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Max Bell, MD, PHD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Daniel Hertberg, MD, PHD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 4, 2019
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08