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Change and prognostic significance of cardio-renal parameters in cardiosurgical interventions

Change and prognostic significance of cardio-renal parameters in cardiosurgical interventions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028812
Enrollment
120
Registered
2022-04-12
Start date
2022-04-18
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N18

Interventions

Group 1: Patients receiving cardiac surgery intervention Group 1 Patients with high-grade aortic valve stenosis who receive surgical aortic valve replacement group 2 Patients with severe mitral valve

Sponsors

Universitätsmedizin Göttingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients in whom the indication for one of the cardiosurgical therapies was made due to a symptomatic heart disease in the indications mentioned under groups 1-5: - Age >= 18 years - Patients able to consent and cooperate - Written consent to study participation Group 1 Patients with high-grade aortic valve stenosis who receive surgical aortic valve replacement group 2 Patients with severe mitral valve regurgitation who receive surgical mitral valve reconstruction/replacement group 3 Patients with severe tricuspid regurgitation who receive surgical tricuspid valve reconstruction/replacement group 4 Patients with CHD who receive ACVB surgery and do not have defects > grade 2 4A) with ejection fraction =50% (control group) 4B) with ejection fraction <40% group 5 Patients receiving LVAD implantation In this group, due to the limited use of the method, it is unlikely that a high number of cases will be reached, so this group will be recruited in an exploratory approach until the other groups have been completed. A maximum number of N=20 is provided.

Exclusion criteria

Exclusion criteria: Patients after a kidney transplant or requiring dialysis - Chronic renal failure CKD stage > G5 (<15 ml/min according to CKD EPI formula) - Autosomal Dominant Polycystic Kidney Disease (ADPKD) - History of intrarenal disease (e.g. glomerulonephritis, interstitial nephritis) - Current acute kidney injury - Postrenal obstruction - Need for therapy with catecholamines or inotropics at inclusion in the study - Patients after heart transplantation - Established precapillary pulmonary hypertension - Circumstances that could interfere with the results of the Doppler sonographic evaluation or the biomarkers (e.g. significantly restrictive respiratory diseases, strongly fluctuating blood pressure values, etc.) - Pregnancy or lactation A board of two nephrologists assessed the exclusion criteria - the presence of acute renal failure and the severity of CKD. Group 4A (control group) - EF<50% Group 4B - EF=40%

Design outcomes

Primary

MeasureTime frame
Evaluation of renal venous congestion in the different groups of patients receiving cardiac surgery

Secondary

MeasureTime frame
Correlation of the renal-venous congestion and the laboratory biomarkers with the renal outcome of the patients.

Countries

Germany

Contacts

Public ContactManuel Wallbach

Universitätsmedizin Göttingen

M.Wallbach@gmx.de+495513960400

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026