- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03727204
Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
Study Overview
Status
Intervention / Treatment
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 and 4th. In addition, patients are followed with markers of kidney function, fluid balance and invasive measures of mean arterial pressure and central venous pressure.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Aarhus University Hospital, Department of Anaesthesiology
-
-
-
-
-
Johannesburg, South Africa, 2196
- Department of Anesthesiology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Aarhus University Hospital
100 patients undergoing on-pump cardiac surgery at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
|
All participants will undergo 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
|
All participants will undergo on-pump cardiac surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 month
|
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
|
1 month
|
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.
|
1 month
|
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, medial and lateral (e' and a'), and measures define grades of diastolic dysfunction from normal to grade I-III, with grade III being the worst.
|
1 month
|
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.
|
1 month
|
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.
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Peter Juhl-Olsen, MD, PhD, Department of Anaesthesiology, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-10-72-267-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
University Hospital, GhentWithdrawn
-
Beni-Suef UniversityCairo UniversityRecruitingAKI - Acute Kidney InjuryEgypt
-
University Hospital MuensterBaxter Healthcare CorporationCompletedAcute Kidney Injury (AKI)Spain, France, United States, Turkey, Germany, Egypt, Italy, Libyan Arab Jamahiriya, Malta, North Macedonia, Palestinian Territory, occupied, Russian Federation, Saudi Arabia, Slovenia
-
Chinese PLA General HospitalBeijing Tsinghua Changgeng HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Chinese PLA General HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Ain Shams UniversityRecruiting
-
Astellas Pharma IncCompleted
-
South Egypt Cancer InstituteCompletedAcute Kidney Injury (AKI)Egypt
Clinical Trials on On-pump cardiac surgery
-
University of AlexandriaNot yet recruitingDelirium | Open Heart SurgeryEgypt
-
Centre hospitalier de l'Université de Montréal...Not yet recruitingDisorder; Heart, Functional, Postoperative, Cardiac SurgeryCanada
-
Medtronic ItaliaCompletedCoronary Artery DiseaseSwitzerland, Italy
-
Universität MünsterRecruitingVasoplegia | Vasoplegic ShockGermany
-
Khon Kaen UniversityCompleted
-
West China HospitalRecruitingOn-pump Valve Surgery or CABGChina
-
Lei LiUnknownDeep Venous Thrombosis | Gynecologic Neoplasm | Ankle Motion | Abdominal BreathingChina
-
The University of Texas Health Science Center,...TerminatedHeart Failure | LVADUnited States
-
Second Affiliated Hospital, School of Medicine,...Not yet recruiting
-
Papworth Hospital NHS Foundation TrustRecruitingAortic Valve Stenosis | Coronary Artery Bypass Graft | Mitral Valve Disease | Tricuspid Valve Disease | Aorta DiseaseUnited Kingdom