Renal Venous Flow and Cardiac Surgery-associated Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753607
• Other study ID #: AZ 208/17 and AZ 216/17
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardio-Renal Syndrome
• Cardiorenal Syndrome

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