Early Add-On Combination of GLP-1 Receptor Agonist and SGLT2 Inhibitor in People With Cardiovascular-Kidney-Metabolic Stage 2-3
NCT07465926
Body Weight, Cardiovascular Disease Risk Factor
View Trial DetailsNCT Number: NCT01947829
Session-to-session variations in delivered Kt/V that may cause failure to achieve the prescribed dialysis dose may be significant in regular clinical practice. To date, this is not recognized due to monthly blood Kt/V measurements only. Suboptimal delivery of prescribed dialysis dose may be caused by low effective treatment time, vascular access dysfunction, hemodynamic stability, blood pump speed, membrane influences, lab value variability or others which may vary from session to session. Patients close to recommended target limits of dialysis dose may thus be "randomly" attributed to be adequately or inadequately dialyzed. Therefore, in the literature, use of average Kt/V values is recommended.
Adimea allows easy Kt/V determination in every session and thus documentation of the monthly achieved Kt/V in patients who repeatedly miss Kt/V. Knowledge, therefore, of session-to-session variability as well as knowledge of dialysis dose monitoring at every dialysis may enhance and secure delivery of adequate dialysis.
The main objective is the estimation of the pooled within-patient SDs (standard deviation) for single treatment Adimea and of urea kinetic modeling (UKM)/ blood spKt/V. Failure of Kt/V>1.2 delivery as well as its potential causes will be assessed. spKt/V target achievement is assessed by monitoring dose by Adimea at every dialysis. This shall demonstrate that session-to-session variability can be decreased with usage of Adimea.
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Notify Me18 year and older
All sexes
Observational
Beijing Friendship Hospital,Capital Medical University, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Six months prospective
Time frame: Six months prospective
Dialysis time per session
Time frame: 6 months prospective
Initial blood flow rate [ml/min] at the beginning of dialysis session.
Time frame: 6 months prospective
Initial dialysate flow rate [ml/min] at the beginning of dialysis session.
Time frame: 6 months prospective
Ultrafiltration volume [ml] reached at the end of dialysis session.
Time frame: 6 months prospective
Membrane surface size [m2] of the dialyser used during dialysis session.
Time frame: 6 months prospective
Hemoglobin level [mmol/l or g/dl] before dialysis.
Time frame: 6 months prospective
Hematocrit level [%] before dialysis.
Time frame: 6 months prospective
Intact parathyroid hormone level [pmol/l or ng/l] before dialysis.
Time frame: 6 months prospective
C-reactive protein level [mg/l or g/dl] before dialysis.
B.Braun Avitum AG
Industry
Acronym: IVP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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