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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03753607
Other study ID # AZ 208/17 and AZ 216/17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 20, 2018
Est. completion date November 24, 2023

Study information

Verified date November 2023
Source University of Giessen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Germany University Hospital Giessen and Marburg-Campus Giessen, Department of Cardiovascular Surgery & Department of Nephrology Giessen Hessen

Sponsors (1)

Lead Sponsor Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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

Outcome

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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