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

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ClinicalTrials.gov Identifier: NCT03974347
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Max Bell, Karolinska Institutet

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
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).


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Methods for Early Detection of Acute Kidney Injury After Heart Surgery
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort
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



Primary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: 48 hours ]
    Acute Kidney Injury defined by KDiGO criteria


Secondary Outcome Measures :
  1. 30 day Mortality [ Time Frame: 30 days ]
    Death occurring up to 30 days after cardiac surgery


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974347


Contacts
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Contact: Mårten Renberg, MD 004651772066 marten.renberg@sll.se
Contact: Claire Stigare, MD, PhD 004651772066 claire.rimes-stigare@sll.se

Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Max Bell, MD, PHD Karolinska Institutet
Study Director: Daniel Hertberg, MD, PHD Karolinska Institutet

Publications:
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Responsible Party: Max Bell, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03974347     History of Changes
Other Study ID Numbers: 2019-02319
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If the study data set is released it will be anonymized so that no personal data is retained and no individual can be identified from the data by those outside of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Max Bell, Karolinska Institutet:
cardiac surgery
renal resistive index
creatinine clearance

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases