Renal Venous Flow and Cardiac Surgery-associated Acute Kidney Injury

Completed

• Conditions: Acute Kidney Injury; Cardiorenal Syndrome

• Registration Number: NCT03753607
• Lead Sponsor: University of Giessen

Brief 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).

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.

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-27
• Study Start: 2018-12-20
• Primary Completion: 2022-01-14
• Status Verified: 2023-11
• Study Completion: 2023-11-24
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Giessen and Marburg-Campus Giessen, Department of Cardiovascular Surgery & Department of Nephrology; 🇩🇪 Giessen, Hessen, Germany