Reduction of occurence of Acute Kidney Injury through administration of angiotensin-II

Biomarker-guided implementation of angiotensin-II (AT-II) to reduce the occurrence of kidney damage after cardiac surgery - AIDED

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003088-87-DE

Enrollment

Registered

2021-09-16

Start date

2021-11-22

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

Cardiac surgical patients at high risk for AKI MedDRA version: 21.1 Level: PT Classification code 10069339 Term: Acute kidney injury System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.1 Level: LLT Classification code 10080266 Term: Stage 1 acute kidney injury System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.1 Level: LLT Classification code 10080269 Term: Stage 2 acute kidney injury System Organ Class: 10038359 - Renal and urinary disorde

Interventions

Trade Name: GIAPREZA 2.5 mg/ml concentrate for solution for infusion angiotensin II Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ANGIOTENSIN II CAS Number: 4474-91-3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients scheduled for cardiac surgery with cardiopulmonary bypass (CPB), 2. 18 years of age or older, 3. cardiac index > 2.1 l/min per square meter, 4. Written informed consent. Registered patients will be randomized only if 1. ?-renin (difference between post- and pre-operation) = 3.7 µU/ml 4h after CPB. 2. postoperative hypotension requiring vasopressors Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39

Exclusion criteria

Exclusion criteria: 1. Preexisting AKI (stage 1 and higher) 2. Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP) 3. Pregnant women, breastfeeding women and women of childbearing potential 4. Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis 5. Chronic kidney disease with eGFR < 20 ml/min/1.73m2 6. Dialysis dependent CKD 7. Prior kidney transplant within the last 12 months 8. Emergency surgery in the context of an acute coronary syndrome 9. Hypersensitivity to the active substance, or to any of the excipients of the study medication 10. Bronchospasm 11. Liver failure 12. Mesenteric ischemia 13. Participation in another intervention trial in the past 3 months 14. Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator 15. Persons held in an institution by legal or official order

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to investigate the efficacy of Angiotensin-II vs. standard of care on the biomarkers [TIMP-2][IGFBP7] in high-risk patients undergoing cardiac surgery.;Secondary Objective: • occurrence of AKI within 72h after cardiac surgery • occurrence of moderate and severe AKI within 72h after cardiac surgery • amount of volume application • transient (<72h) and persistent (<72h) AKI • fluid status • dose and duration of vasopressor use • creatinine clearance on day one after cardiac surgery • free-days through day 28 of vasoactive medications and mechanical ventilation • renal recovery at day 90 • 30-day, 60-day and 90-day mortality • length of ICU stay • length of hospital stay • use and duration of renal replacement therapy within hospital stay • use of RRT at days 30, 60, 90 • MAKE90 • Effect of ACEi/ARBs use on the AT II effect • Correlation between the severity of hyperreninemia and the AT II effect;Primary end point(s): • kidney damage after cardiac surgery identified by the difference between [TIMP-2][IGFBP7] levels 12h after randomization and [TIMP-2]*[IGFBP7] levels at randomization;Timepoint(s) of evaluation of this end point: 12 h after start of intervention	—

Measure

Time frame

Main Objective: The primary objective of this trial is to investigate the efficacy of Angiotensin-II vs. standard of care on the biomarkers [TIMP-2]*[IGFBP7] in high-risk patients undergoing cardiac surgery.;Secondary Objective: • occurrence of AKI within 72h after cardiac surgery • occurrence of moderate and severe AKI within 72h after cardiac surgery • amount of volume application • transient (<72h) and persistent (<72h) AKI • fluid status • dose and duration of vasopressor use • creatinine clearance on day one after cardiac surgery • free-days through day 28 of vasoactive medications and mechanical ventilation • renal recovery at day 90 • 30-day, 60-day and 90-day mortality • length of ICU stay • length of hospital stay • use and duration of renal replacement therapy within hospital stay • use of RRT at days 30, 60, 90 • MAKE90 • Effect of ACEi/ARBs use on the AT II effect • Correlation between the severity of hyperreninemia and the AT II effect;Primary end point(s): • kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 12h after randomization and [TIMP-2]*[IGFBP7] levels at randomization;Timepoint(s) of evaluation of this end point: 12 h after start of intervention

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Secondary

Measure	Time frame
Secondary end point(s): • occurrence of AKI within 72h after cardiac surgery (according to the KDIGO criteria) • occurrence of moderate and severe AKI within 72h after cardiac surgery (according to the KDIGO stage 2 and 3) • amount of volume application • transient (<72h) and persistent (<72h) AKI • fluid status • dose and duration of vasopressor use • creatinine clearance on day one after cardiac surgery • free-days through day 28 of vasoactive medications and mechanical ventilation • renal recovery at day 90 (renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery) • 30-day, 60-day and 90-day mortality • length of ICU stay • length of hospital stay • use and duration of renal replacement therapy within hospital stay • use of RRT at days 30, 60, 90 • MAKE90 (major adverse kidney events consisting of mortality, dialysis dependency, persistent renal dysfunction (defined as serum creatinine = 2x compared to baseline value) at day 90 • Effect of ACEi/ARBs use on the AT II effect • Correlation between the severity of hyperreninemia and the AT II effect ;Timepoint(s) of evaluation of this end point: 72 hours after cardiac surgery 30 days after cardiac surgery 60 days after cardiac surgery 90 days after cardiac surgery	—

Measure

Time frame

Secondary end point(s): • occurrence of AKI within 72h after cardiac surgery (according to the KDIGO criteria) • occurrence of moderate and severe AKI within 72h after cardiac surgery (according to the KDIGO stage 2 and 3) • amount of volume application • transient (<72h) and persistent (<72h) AKI • fluid status • dose and duration of vasopressor use • creatinine clearance on day one after cardiac surgery • free-days through day 28 of vasoactive medications and mechanical ventilation • renal recovery at day 90 (renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery) • 30-day, 60-day and 90-day mortality • length of ICU stay • length of hospital stay • use and duration of renal replacement therapy within hospital stay • use of RRT at days 30, 60, 90 • MAKE90 (major adverse kidney events consisting of mortality, dialysis dependency, persistent renal dysfunction (defined as serum creatinine = 2x compared to baseline value) at day 90 • Effect of ACEi/ARBs use on the AT II effect • Correlation between the severity of hyperreninemia and the AT II effect ;Timepoint(s) of evaluation of this end point: 72 hours after cardiac surgery 30 days after cardiac surgery 60 days after cardiac surgery 90 days after cardiac surgery

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Countries

Germany

Contacts

Public ContactDept. of Anesthesiology

University Hospital Muenster

aki@anit.uni-muenster.de+4902518347252

Outcome results

None listed

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