Acute Kidney InjuryNCT03753607
Renal Venous Flow and Cardiac Surgery-associated Acute Kidney Injury
An observational study of Acute Kidney Injury and Cardiorenal Syndrome, run by University of Giessen at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cardiorenal Syndrome
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 20 Dec 2018to 24 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery (with/without cardiopulmonary bypass) at Department of Cardiovascular Surgery, University Hospital Giessen and Marburg, Campus Giessen
Who may be able to join
- Subjects older than 18 years
- Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
- Subjects who signed informed consent forms
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Giessen and Marburg-Campus Giessen, Department of Cardiovascular Surgery & Department of Nephrology
Giessen, Hesse, 35392
About this study
Official title: 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).
Read the 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.
- Conditions
- Acute Kidney Injury, Cardiorenal Syndrome
- Being tested
- No intervention
- Medical subject headings
- Acute Kidney Injury, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between perioperative changes in Doppler-derived renal venous venous flow and CSA-AKI
Doppler-derived renal venous flow
Measured: preoperative, 24 hours postoperative, hospital discharge
Secondary outcomes (2)
Association of changes in postoperative renal venous flow profiles with renal recovery at hospital discharge
Doppler-derived renal venous flow
Measured: Measured at Day 1 and Day 7 postoperative
Estimated GFR trajectory up to 3 months post-cardiac surgery relative to kidney
Estimated GFR
Measured: Measured at 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start20 Dec 2018
- Primary completion14 Jan 2022
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faeq Husain-Syed, University of Giessen
- Investigators
- Andreas Böning, M.D., Study director, University Hospital Giessen and MarburgHorst-Walter Birk, M.D., Study director, University Hospital Giessen and Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753607
- Sponsor's protocol ID
- AZ 208/17 and AZ 216/17
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2018
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30429498Beaubien-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.
PubMed 30371304Iida 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.
PubMed 27179835Nijst 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.
PubMed 28711449
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Doppler-derived Renal Venous Flow and Adverse Renal Outcomes Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03753607
- Acronym / sponsor ID
- AZ 208/17 and AZ 216/17
- Conditions
- Acute Kidney Injury, Cardiorenal Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery (with/without cardiopulmonary bypass) at Department of Cardiovascular Surgery, University Hospital Giessen and Marburg, Campus Giessen
Key inclusion criteria (3 listed)
- Subjects older than 18 years
- Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
- Subjects who signed informed consent forms
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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
2 secondary outcomes
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
Estimated GFR trajectory up to 3 months post-cardiac surgery relative to kidney
Time frame: Measured at 3 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Results publication: PubMed 30429498Shimada 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.
- Results publication: PubMed 30371304Beaubien-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.
- Results publication: PubMed 27179835Iida 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.
- Results publication: PubMed 28711449Nijst 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Böning, M.D. study director
University Hospital Giessen and Marburg
Horst-Walter Birk, M.D. study director
University Hospital Giessen and Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Cardiorenal Syndrome, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between perioperative changes in Doppler-derived renal venous venous flow and CSA-AKI (time frame: preoperative, 24 hours postoperative, hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753607, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.