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Renal Venous Flow and Cardiac Surgery-associated Acute Kidney Injury

NCT ID: NCT03753607

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-20

Study Completion Date

2023-11-24

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Cardiorenal Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Faeq Husain-Syed

Senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Böning, M.D.

Role: STUDY_DIRECTOR

University Hospital Giessen and Marburg

Horst-Walter Birk, M.D.

Role: STUDY_DIRECTOR

University Hospital Giessen and Marburg

Locations

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

Giessen, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 30429498 (View on PubMed)

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 Prospective Observational Cohort Study. J Am Heart Assoc. 2018 Oct 2;7(19):e009961. doi: 10.1161/JAHA.118.009961.

Reference Type RESULT
PMID: 30371304 (View on PubMed)

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.2016.03.016. Epub 2016 May 11.

Reference Type RESULT
PMID: 27179835 (View on PubMed)

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 Jul 12.

Reference Type RESULT
PMID: 28711449 (View on PubMed)

Other Identifiers

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AZ 208/17 and AZ 216/17

Identifier Type: -

Identifier Source: org_study_id