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Cerebral oxygen saturation as an indicator of postoperative cardio-renal organ function and neurocognitive outcome in patients undergoing transcatheter aortic valve implantation.

Cerebral oxygen saturation as an indicator of postoperative cardio-renal organ function and neurocognitive outcome in patients undergoing transcatheter aortic valve implantation.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00020813
Enrollment
140
Registered
2022-12-12
Start date
2020-10-12
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

Hemodynamic change and its outcome-relevant influence during transcatheter aortic valve implantation. I35.0

Interventions

Group 1: Pre-operative neurocognitive testing Pre-operative blood sampling at the onset of anesthesia Recording of anesthesia data/hemodynamics Post-operative blood sampling on 1st post-operative day

Sponsors

Immanuel Klinikum Bernau, Herzzentrum Brandenburg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Elective transcatheter aortic valve implantation (TAVI). No contraindication to neurocognitive testing Ability to understand the scope and significance of the study Written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Emergency intervention Dialysis patients Patient (or proxy) is unable to provide written informed consent to participate in the give written informed consent for participation in the study Diseases, due to which neurocognitive testing is not possible Attending physician does not recommend participation in the study

Design outcomes

Primary

MeasureTime frame
AKI incidence in patients above versus below median cerebral saturation (rSO2).

Secondary

MeasureTime frame
- ? creatinine and ? NT-proBNP in patients* above versus below the median cerebral saturation (rSO2). - Cumulative cerebral desaturation (AUC, maximum, minimum). - Time [min] rSO2 <50% / frequency of episodes. - Time to MAD/rSO2 recovery (+/-10% from baseline) after RVP. - Changes in cognitive tests

Countries

Germany

Contacts

Public ContactAnja Haase-Fielitz

Immanuel Klinikum Bernau Herzzentrum BrandenburgUniversitätsklinikum der Medizinischen Hochschule Brandenburg Theodor Fontane

anja.haase-fielitz@immanuelalbertinen.de+49 3338 69 4649

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026