Renal Venous Flow and Cardiac Surgery-associated Acute Kidney Injury

November 28, 2023 updated by: Faeq Husain-Syed, University of Giessen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Giessen, Hessen, Germany, 35392
        • University Hospital Giessen and Marburg-Campus Giessen, Department of Cardiovascular Surgery & Department of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing cardiac surgery (with/without cardiopulmonary bypass) at Department of Cardiovascular Surgery, University Hospital Giessen and Marburg, Campus Giessen

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperative, 24 hours postoperative, hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at Day 1 and Day 7 postoperative
Estimated GFR trajectory up to 3 months post-cardiac surgery relative to kidney
Time Frame: Measured at 3 months post-surgery
Estimated GFR
Measured at 3 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Study Director: Andreas Böning, M.D., University Hospital Giessen and Marburg
  • Study Director: Horst-Walter Birk, M.D., University Hospital Giessen and Marburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2018

Primary Completion (Actual)

January 14, 2022

Study Completion (Actual)

November 24, 2023

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ 208/17 and AZ 216/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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