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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03974347
• Collaborator: (none)
• Enrollment: 200
• Anticipated Duration (Months): 32

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury

Detailed Description

Acute Kidney Injury is common after Cardiac surgery and occurs in up to 20% of patients (Ref Rydén).

This study will evaluate two new methods for the early detection of acute kidney injury in 200 patients undergoing elective cardiac surgery at the Karolinska Hospital.

These methods are:

1. Ultrasound based measurement of the kidneys blood flow profile measured using renal resistive index (RRI). This will be measured prior and within 4 hours post surgery. Ref Herzberg, Le Dorze.

2. Urine creatinine clearance will be measured in the first four hours after cardiac surgery.

The investigators will also measure known renal injury markers in blood and urine samples post operatively. These include Neutrophil gelatinise-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases (TIMP-2), Insulin-like growth factor-binding protein 7 (IGFBP7), Kidney Injury Molecule 1 (KIM-1), Nephroclear, Interleukin 18 (IL-18), Fatty acid-binding protein (L-FABP), Fibulin-1, cystatin C och albumin.

The new methods of AKI detection will be used to build a statistical model to predict AKI after cardiac surgery. We will determine whether the addition of renal injury markers and epidemiological factors known to be associated with the development of AKI (variables such as age, known chronic renal dysfunction or heart failure) can improve precision in diagnosis.

AKI will be defined by the Kidney Disease improving Global outcomes (KDIGO) criteria (Ref KDIGO KDIGO Clinical Practice Guideline for Acute Kidney Injury, Khwaja A).

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: New Methods for Early Detection of Acute Kidney Injury After Heart Surgery
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Acute Kidney Injury [48 hours]

   Acute Kidney Injury defined by KDiGO criteria

Secondary Outcome Measures

1. 30 day Mortality [30 days]

   Death occurring up to 30 days after cardiac surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• Unable to give consent

• Previously received a renal transplant

• Renal failure requiring dialysis prior to surgery

• Persistent atrial fibrillation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Max Bell, MD, PHD, Karolinska Institutet
• Study Director: Daniel Hertberg, MD, PHD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Le Dorze M, Bouglé 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. Review.
• Rydén 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.
• Rydén 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.

• Responsible Party: Max Bell, Associate Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03974347
• Other Study ID Numbers: 2019-02319
• First Posted: Jun 4, 2019
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Max Bell, Associate Professor, Karolinska Institutet: cardiac surgery; renal resistive index; creatinine clearance
• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Aug 18, 2022