Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471621
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-24
Brief Title:
Precision Medicine in Cardiovascular Surgery Associated Acute Kidney Injury
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
PrEcision Medicine in the Management of Cardiovascular Surgery Associated AKI - PEAK a Prospective Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEAK
Brief Summary:
The goal of this prospective observational study is to define a risk profile for cardiovascular surgery associated acute kidney injury AKI using clinical patient characteristics operation parameters as well as blood and urine laboratory values
The main question it aims to answer is
Does a combination of the factors mentioned above better predict patient outcome than classical factors used to date in clinical practice
Participants of this study are adults aged 18 and above who are scheduled for elective heart or main artery surgery and who have given written informed consent
The main question it aims to answer is
Does a combination of the factors mentioned above better predict patient outcome than classical factors used to date in clinical practice
Participants of this study are adults aged 18 and above who are scheduled for elective heart or main artery surgery and who have given written informed consent
Detailed Description:
The difficulty of precisely predicting AKI following major surgery is a clinical challenge and unmet need as treatment should be introduced within 24-48 hours In addition there is no available treatment to date apart from supportive therapy such as renal replacement therapy
Therefore early identification of patient-specific biomarkers and other clinical predictors could help to better understand the association with AKI and other patient outcomes In addition to the classical risk factors age diabetes pre-existing CKD frailty might represent another important variable as shown in previous observational studies Importantly frailty is not unique to age although it occurs in approximately 25 of those over 65 and affects more than half of the population aged 85 and older as it has been shown to be highly prevalent in hospitalized patients andor patients with CKD Furthermore in preclinical studies the serum protein Fetuin-A was identified as potential biomarker for vascular surgery associated AKI
PEAK is a single center prospective observational study involving several clinics at the University Hospital Bern Besides from demographic data and perioperative parameters blood and urine are collected with high granularity during and immediately after surgery 15min after the first cut start and end of cardiopulmonary bypass CBP or aortic clamping X-clamp 4 hours after surgery and at day 1 2 3 and 7 or discharge post-surgery In addition renal function will be assessed at day 90 Furthermore study participants will answer the Edmonton frailty questionnaire at baseline and at day 90
Therefore early identification of patient-specific biomarkers and other clinical predictors could help to better understand the association with AKI and other patient outcomes In addition to the classical risk factors age diabetes pre-existing CKD frailty might represent another important variable as shown in previous observational studies Importantly frailty is not unique to age although it occurs in approximately 25 of those over 65 and affects more than half of the population aged 85 and older as it has been shown to be highly prevalent in hospitalized patients andor patients with CKD Furthermore in preclinical studies the serum protein Fetuin-A was identified as potential biomarker for vascular surgery associated AKI
PEAK is a single center prospective observational study involving several clinics at the University Hospital Bern Besides from demographic data and perioperative parameters blood and urine are collected with high granularity during and immediately after surgery 15min after the first cut start and end of cardiopulmonary bypass CBP or aortic clamping X-clamp 4 hours after surgery and at day 1 2 3 and 7 or discharge post-surgery In addition renal function will be assessed at day 90 Furthermore study participants will answer the Edmonton frailty questionnaire at baseline and at day 90
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BASEC-Nr 2023-02024 | OTHER | None | None |