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Completed

NCT Number: NCT03753607

Renal Venous Flow and Cardiac Surgery-associated Acute Kidney Injury

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Giessen and Marburg-Campus Giessen, Department of Cardiovascular Surgery & Department of Nephrology

Giessen, Hesse, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Association between perioperative changes in Doppler-derived renal venous venous flow and CSA-AKI

    Time frame: preoperative, 24 hours postoperative, hospital discharge

    Doppler-derived renal venous flow

Secondary outcomes

  1. Association of changes in postoperative renal venous flow profiles with renal recovery at hospital discharge

    Time frame: Measured at Day 1 and Day 7 postoperative

    Doppler-derived renal venous flow

  2. Estimated GFR trajectory up to 3 months post-cardiac surgery relative to kidney

    Time frame: Measured at 3 months post-surgery

    Estimated GFR

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Nov 27, 2018
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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