Acute Kidney Injury Clinical Trial
Official title:
Changes in Doppler-derived Renal Venous Flow and Adverse Renal Outcomes Following Cardiac Surgery
Verified date | November 2023 |
Source | University of Giessen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 200 |
Est. completion date | November 24, 2023 |
Est. primary completion date | January 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Giessen and Marburg-Campus Giessen, Department of Cardiovascular Surgery & Department of Nephrology | Giessen | Hessen |
Lead Sponsor | Collaborator |
---|---|
University of Giessen |
Germany,
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 — View Citation
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 — View Citation
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 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Association between perioperative changes in Doppler-derived renal venous venous flow and CSA-AKI | Doppler-derived renal venous flow | preoperative, 24 hours postoperative, hospital discharge | |
Secondary | Association of changes in postoperative renal venous flow profiles with renal recovery at hospital discharge | Doppler-derived renal venous flow | Measured at Day 1 and Day 7 postoperative | |
Secondary | Estimated GFR trajectory up to 3 months post-cardiac surgery relative to kidney | Estimated GFR | Measured at 3 months post-surgery |
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