Renal Venous Flow and Cardiac Surgery-associated Acute Kidney Injury

NCT03753607 | Completed DMC

• 1 other identifier: AZ 208/17 and AZ 216/17
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Kidney Injury; Cardiorenal Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Measured at Day 1 and Day 7 postoperative

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

  Measured at 3 months post-surgery

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

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

Giessen, Hesse, 35392, Germany

Location

Related Publications (4)

• 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.

  PMID: 30429498 RESULT

• 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.

  PMID: 30371304 RESULT

• 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.

  PMID: 27179835 RESULT

• 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.

  PMID: 28711449 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be flash-frozen for biomarker analyses.

MeSH Terms

Conditions

Acute Kidney Injury; Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andreas Böning, M.D.

  University Hospital Giessen and Marburg

  STUDY DIRECTOR

• Horst-Walter Birk, M.D.

  University Hospital Giessen and Marburg

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 27, 2018
• Study Start: December 20, 2018
• Primary Completion: January 14, 2022
• Study Completion: November 24, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

DE (1)