NCT03727204

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

October 9, 2018

Last Update Submit

April 8, 2021

Conditions

Acute Kidney InjuryAcute Renal FailureCardiac Surgery

Keywords

UltrasoundUltrasonographic flow measuresFluid treatment

Outcome Measures

Primary Outcomes (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.

    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.

    4 days

Secondary Outcomes (6)

  • Correlation between changes in organ-specific flow measurements and the corresponding biomarkers.

    1 month

  • Establishment of the most optimal organ specific cut-off values and the development of AKI.

    1 month

  • Fluid balance and AKI

    1 month

  • Diastolic dysfunction and AKI

    1 month

  • Organ-specific flow measures and mortality

    1 month

  • +1 more secondary outcomes

Study Arms (2)

Aarhus University Hospital

100 patients undergoing on-pump cardiac surgery at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand

Procedure: On-pump cardiac surgery

Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand

50 patients undergpoing on-pump cardiac surgery at at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand

Procedure: On-pump cardiac surgery

Interventions

On-pump cardiac surgeryPROCEDURE

All participants will undergo on-pump cardiac surgery

Aarhus University HospitalCharlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand

Eligibility Criteria

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

Patients scheduled for on-pump cardiac surgery at the Department of Cardiothoracic \& vascular surgery, Aarhus University Hospital. The study will include 100 patients from Denmark.

You may qualify if:

  • All patients ≥ 18 years
  • Scheduled for on-pump cardiac surgery
  • Oral and written consent
  • AND
  • 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;
  • +1 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital, Department of Anaesthesiology

Aarhus, 8200, Denmark

Location

Department of Anesthesiology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand

Johannesburg, 2196, South Africa

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

  • Peter Juhl-Olsen, MD, PhD

    Department of Anaesthesiology, Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2018

First Posted

November 1, 2018

Study Start

October 15, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)ZA(1)