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Renal Venous Flow and Cardiac Surgery-associated Acute Kidney Injury

NCT03753607 — Completed, 200 participants, University of Giessen

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Changes in Doppler-derived Renal Venous Flow and Adverse Renal Outcomes Following Cardiac Surgery

RegistryNCT03753607
StatusCompleted
Study typeObservational
Enrollment200 (Actual)
SponsorUniversity of Giessen (Other)
ConditionsAcute Kidney Injury, Cardiorenal Syndrome
InterventionsNo intervention (Other)
Datesstart 2018-12-20, primary completion 2022-01-14, completion 2023-11-24, first posted 2018-11-27, last updated 2023-12-01
Locations1 site in Germany

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-Summary

The prospective single-center study investigates the association between changes in Doppler-derived renal venous flow and cardiac surgery-associated acute kidney injury (CSA-AKI).

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+Detailed description

CSA-AKI is a common postoperative complication in patients undergoing open heart surgery, and is associated with increased mortality and morbidity. Venous congestion has been identified as the principal cause of cardiorenal decompensation in patients with heart failure but the relative contribution of congestion-driven renal function decline in CSA-AKI is not well studied.

The prospective single-center study investigates whether serial Doppler-derived renal venous flow assessments could help identify subset of patients with cardiorenal syndrome and subclinical renal congestion at high risk of CSA-AKI.

+Arms and interventions

  • No intervention (Other): No intervention

+Outcome measures

Primary outcomes

  • Association between perioperative changes in Doppler-derived renal venous venous flow and CSA-AKI [preoperative, 24 hours postoperative, hospital discharge]: Doppler-derived renal venous flow

Secondary outcomes

  • Association of changes in postoperative renal venous flow profiles with renal recovery at hospital discharge [Measured at Day 1 and Day 7 postoperative]: Doppler-derived renal venous flow
  • Estimated GFR trajectory up to 3 months post-cardiac surgery relative to kidney [Measured at 3 months post-surgery]: Estimated GFR

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

Inclusion criteria:

1. Subjects older than 18 years
2. Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
3. Subjects who signed informed consent forms

Exclusion Criteria:

1. Patients requiring mechanical ventilation
2. Patients with mechanical circulatory assist devices or extracorporeal membrane oxygenation
3. Patients with stage 3 AKI with renal replacement therapy (RRT) or life- threatening volume overload treated with RRT
4. Stage ≥4 chronic kidney disease (CKD) stage
5. CKD requiring extracorporeal or peritoneal ultrafiltration for diuretic-resistant volume overload, 6) 6) Prediagnosed glomerulonephritis
6. Autosomal dominant polycystic kidney disease, postrenal obstruction, or solid organ transplantation
7. Anticipated life expectancy of <12 months
8. Likelihood of receiving advanced therapy (mechanical circulatory assist device/cardiac transplant)
9. Pregnancy or possibility of pregnancy in the next 3 months
10. Rhabdomyolysis

+Locations (1)

FacilityCityCountryStatus
University Hospital Giessen and Marburg-Campus Giessen, Department of Cardiovascular Surgery & Department of NephrologyGiessen, HesseGermany

+Publications

  • Results publication: Shimada S, Hirose T, Takahashi C, Sato E, Kinugasa S, Ohsaki Y, Kisu K, Sato H, Ito S, Mori T. Pathophysiological and molecular mechanisms involved in renal congestion in a novel rat model. Sci Rep. 2018 Nov 14;8(1):16808. doi: 10.1038/s41598-018-35162-4. PMID 30429498
  • Results publication: Beaubien-Souligny W, Benkreira A, Robillard P, Bouabdallaoui N, Chasse M, Desjardins G, Lamarche Y, White M, Bouchard J, Denault A. Alterations in Portal Vein Flow and Intrarenal Venous Flow Are Associated With Acute Kidney Injury After Cardiac Surgery: A Prospective Observational Cohort Study. J Am Heart Assoc. 2018 Oct 2;7(19):e009961. doi: 10.1161/JAHA.118.009961. PMID 30371304
  • Results publication: Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11. PMID 27179835
  • Results publication: Nijst P, Martens P, Dupont M, Tang WHW, Mullens W. Intrarenal Flow Alterations During Transition From Euvolemia to Intravascular Volume Expansion in Heart Failure Patients. JACC Heart Fail. 2017 Sep;5(9):672-681. doi: 10.1016/j.jchf.2017.05.006. Epub 2017 Jul 12. PMID 28711449

+Investigators

  • Andreas Böning, M.D., Study director, University Hospital Giessen and Marburg
  • Horst-Walter Birk, M.D., Study director, University Hospital Giessen and Marburg

My Notes