Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727204
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Johan Fridolf Hermansen, Aarhus University Hospital

Brief Summary:
Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. This study will evaluate the diagnostic ability of ultrasonographic measures of blood flow in kidneys and liver in predicting AKI after cardiac surgery.

Condition or disease Intervention/treatment
Acute Kidney Injury Acute Renal Failure Cardiac Surgery Procedure: On-pump cardiac surgery

Detailed Description:

Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. The pathophysiology is multifactorial, but renal functions in this setting is determined by a complex interplay between renal perfusion, fluid status, cardiac output, mean arterial pressure and back pressure to venous outflow.

Renal perfusion may be quantified with novel ultrasound techniques. Ultrasonography of the kidney and renal vasculature allows for assessment of renal afferent flow and renal venous flow and, together with venous flow patterns of the portal vein and liver veins, may identify patients in risk of AKI.

The study is observational and will describe the diagnostic accuracy of the ultrasound measures in predicting postoperative AKI. Patients will be examined with ultrasound of kidney and liver flow along with echocardiography on on the day before surgery and on the 1st, 4th and 28th postoperative day. In addition, patients are followed with markers of kidney function, fluid balance and invasive measures of mean arterial pressure and central venous pressure.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients undergoing cardiac surgery
On-pump cardiac surgery at Aarhus University Hospital
Procedure: On-pump cardiac surgery
All participants will undergo on-pump cardiac surgery




Primary Outcome Measures :
  1. The association between the kidney venous ultrasonography flow pattern category on the 1st postoperative day and acute kidney injury (AKI) on the 4th postoperative day. [ Time Frame: 4 days ]

    The flow pattern is grouped as either continuous, biphasic or monophasic based on the appearance.The final analysis will possibly include other flow categories.

    AKI is defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria and graded in four stages from no AKI to stage 1-3 AKI based on serum creatinin change and/or changes in urine output, with stage 3 being the worst stage.



Secondary Outcome Measures :
  1. Correlation between changes in organ-specific flow measurements and the corresponding biomarkers. [ Time Frame: 1 month ]
    Correlations between organ-specific ultrasonography flow measurements and the corresponding biomarkers of kidneys, liver and heart function, for both absolute values of organ-specific flow and perioperative changes in organ-specific flow

  2. Establishment of the most optimal organ specific cut-off values and the development of AKI. [ Time Frame: 1 month ]

    Establishment of the most optimal cut-off (threshold) values for

    • absolute ultrasonography flow values for respectively kidney arterial flow; kidney venous flow; liver vein flow; portal vein flow and the risk of development of AKI.
    • changes in ultrasonography flow values for respectively kidney arterial flow; kidney venous flow; liver vein flow; portal vein flow and the risk of development of AKI.

  3. Fluid balance and AKI [ Time Frame: 1 month ]
    Correlations between accumulated fluid balance on the 1st postoperative day and the development of AKI on the 4th postoperative day.

  4. Diastolic dysfunction and AKI [ Time Frame: 1 month ]
    Correlations between echocardiographic measures of diastolic dysfunction and AKI. The measures include mitral inflow (E and A), mitral annular motion, medíal and lateral (e' and a'), and measures define grades of diastolic dysfunction from normal to grade I-III, with grade III being the worst.

  5. Organ-specific flow measures and mortality [ Time Frame: 1 month ]
    Correlation between organ-specific ultrasonography flow measurements on the day before surgery, the 1st and 4th postoperative day and the mortality at the 1st, 4th and 28th postoperative day.

  6. Organ-specific flow measures and and time of stay in ICU and hospital [ Time Frame: 1 month ]
    Correlation between organ-specific ultrasonography flow measurements on the day before surgery, the 1st and 4th postoperative day and the duration of intensive care stay and duration of hospital stay.


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for on-pump cardiac surgery at the Department of Cardiothoracic & vascular surgery, Aarhus University Hospital.
Criteria

Inclusion Criteria:

  • All patients ≥ 18 years
  • Scheduled for on-pump cardiac surgery
  • Oral and written consent

AND

  • 1 of the following risk factors for development of postoperative AKI may be included:

    • age > 70 years;
    • NYHA (New York Heart Association) 3+4;
    • Insulin dependent diabetes;
    • Glomerular filtration rate < 60 ml/min/1,73 m2;
    • Ejection fraction < 35;
    • Surgery:

      • Combined CABG and valve surgery;
      • Any valve surgery except isolated aortic-valve surgery;
      • Redo surgery;
      • Endocarditis;
    • Peripheral vascular disease.

Exclusion Criteria:

  • Insufficient ultrasonographic imaging of the kidneys;
  • Known morphological kidney disease;
  • Preoperative dialysis;
  • Prior participation in the study.

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): NCT03727204


Contacts
Layout table for location contacts
Contact: Johan F Hermansen, MD + 45 50 73 63 22 johanfhermansen@gmail.com
Contact: Peter Juhl-Olsen, MD, PhD + 45 30 91 10 62 peterjuhlolsen@gmail.com

Locations
Layout table for location information
Denmark
Aarhus University Hospital, Department of Anaesthesiology Recruiting
Aarhus, Denmark, 8200
Contact: Johan F Hermansen, MD    + 45 50 73 63 22    johanfhermansen@gmail.com   
Contact: Peter Juhl-Olsen, MD, PhD    + 45 30 91 10 62    peterjuhlolsen@gmail.com   
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
Investigators
Layout table for investigator information
Study Chair: Peter Juhl-Olsen, MD, PhD Department of Anaesthesiology, Aarhus University Hospital

Additional Information:

Layout table for additonal information
Responsible Party: Johan Fridolf Hermansen, Principal Investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03727204     History of Changes
Other Study ID Numbers: 1-10-72-267-18
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johan Fridolf Hermansen, Aarhus University Hospital:
Ultrasound
Ultrasonographic flow measures
Fluid treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases