- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03727204
Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Aarhus, Danimarca, 8200
- Aarhus University Hospital, Department of Anaesthesiology
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Johannesburg, Sud Africa, 2196
- Department of Anesthesiology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Aarhus University Hospital
100 patients undergoing on-pump cardiac surgery at Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand
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All participants will undergo on-pump cardiac surgery
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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
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All participants will undergo on-pump cardiac surgery
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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.
Lasso di tempo: 4 days
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Correlation between changes in organ-specific flow measurements and the corresponding biomarkers.
Lasso di tempo: 1 month
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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
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1 month
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Establishment of the most optimal organ specific cut-off values and the development of AKI.
Lasso di tempo: 1 month
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Establishment of the most optimal cut-off (threshold) values for
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1 month
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Fluid balance and AKI
Lasso di tempo: 1 month
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Correlations between accumulated fluid balance on the 1st postoperative day and the development of AKI on the 4th postoperative day.
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1 month
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Diastolic dysfunction and AKI
Lasso di tempo: 1 month
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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.
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1 month
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Organ-specific flow measures and mortality
Lasso di tempo: 1 month
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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.
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1 month
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Organ-specific flow measures and and time of stay in ICU and hospital
Lasso di tempo: 1 month
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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.
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1 month
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Peter Juhl-Olsen, MD, PhD, Department of Anaesthesiology, Aarhus University Hospital
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1-10-72-267-18
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .