Cardiac Surgery Clinical Trial
— AIDEDOfficial title:
Biomarker-guided Implementation of Angiotensin-II (AT-II) to Reduce the Occurrence of Kidney Damage After Cardiac Surgery
Verified date | March 2023 |
Source | Westfälische Wilhelms-Universität Münster |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate whether adding angiotensin II to the standard of care is superior compared to the standard of care alone with respect to kidney damage (personalized approach) after cardiac surgery.
Status | Completed |
Enrollment | 64 |
Est. completion date | March 19, 2023 |
Est. primary completion date | December 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients undergoing cardiac surgery with CPB - Cardiac index 2.1l/min per square meter - Written informed consent - D-renin (difference between post- and preoperative) = 3.7 micro Unit/ml 4 h after CPB - Postoperative hypotension requiring vasopressors Exclusion Criteria: - Preexisting AKI (stage 1 and higher) - Patients with cardiac assist devices - Pregnant women, nursing women and women of childbearing potential - Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis - chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30 ml/min - Dialysis dependent chronic kidney disease - Prior kidney transplant within the last to 12 months - Emergency surgery in the context of an acute coronary syndrome - Hypersensitivity to the active substance, or to any of the excipients of the study medication - Bronchospasm - Liver failure - Mesenteric ischemia - Participation in another intervention trial in the past 3 months - Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator - Persons held in an institution by legal or official order |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Muenster | Münster |
Lead Sponsor | Collaborator |
---|---|
Westfälische Wilhelms-Universität Münster | German Research Foundation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | • kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 12h after randomization and [TIMP-2]*[IGFBP7] levels at randomization | The presence of tissue inhibitor of metalloproteinases (TIMP-2) and insulin-like growth-factor binding protein 7 (IGFBP7) in the urine will be measured. | 12 hours after start of intervention | |
Secondary | Occurence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria | 72 hours after cardiac surgery | ||
Secondary | Severity of Acute Kidney Injury | Number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3) | 72 hours after cardiac surgery | |
Secondary | Amount of volume application | 12 hours after start of intervention | ||
Secondary | Fluid status | 12 hours after start of intervention | ||
Secondary | Dose of vasopressor use during intervention | During intervention, an average of 12 hours | ||
Secondary | Creatinine clearance on day one after cardiac surgery | One day after cardiac surgery | ||
Secondary | Free-days through day 28 of vasoactive medications and mechanical ventilation | 28 days after cardiac surgery | ||
Secondary | Renal Recovery | Renal recovery is defined as serum creatinine levels < 0.5 mg/dL higher than baseline serum creatinine | 90 days after cardiac surgery | |
Secondary | Mortality | 30 days after cardiac surgery | ||
Secondary | Mortality | 60 days after cardiac surgery | ||
Secondary | Mortality | 90 days after cardiac surgery | ||
Secondary | Length of ICU (Intensive Care Unit) stay | up to 90 days after cardiac surgery (until discharge) | ||
Secondary | Length of hospital stay | up to 90 days after cardiac surgery (until discharge) | ||
Secondary | Use and duration of renal replacement therapy | Number of patients with renal replacement therapy | up to 90 days after cardiac surgery | |
Secondary | Major adverse kidney events (MAKE) | Major adverse kidney events consisting of mortality, dialysis dependency, persistent renal dysfunction (defined as serum creatinine = 2x compared to baseline value) | 90 days after cardiac surgery | |
Secondary | Effect of Angiotensin converting enzyme inhibitor (ACEi)/angiotensin II receptor blocker (ARBs) use on the effect of angiotensin II | 12 hours after intervention | ||
Secondary | Correlation between the severity of hyperreninemia and the effect of angiotensin II | 12 hours after intervention |
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