M2RLAB for Acute kidney injury (post-cardiac surgery)

Inclusion criteria

• {"criterion_text":"- Patients of both sexes over 18 years of age being able to understand and sign the informed consent."}
• {"criterion_text":"- Patients undergoing elective or emergent valvular and/or coronary heart surgery performed with extracorporeal circulation."}
• {"criterion_text":"- Meet one of the following two criteria: a)\tPresent a preoperative AKI risk ≥ 30% according to the Leicester Cardiosurgery score, if the informed consent form (ICF) is signed before cardiac surgery. b)\tHave signed the ICF within the first 12 hours after the diagnosis of AKI"}
• {"criterion_text":"- Present AKI in the first 48 hours after cardiac surgery, according to one of the classifications defined by the AKIN (Acute Kidney Injury Network) scale."}
• {"criterion_text":"- In the case of women or men of childbearing age, for safety, those who agree to follow the required contraceptive measures from hospital discharge until the end of their participation in the clinical trial."}

Exclusion criteria

• {"criterion_text":"- Stage IV or V CKD (glomerular filtration rate [GFR] < 30 ml/min)"}
• {"criterion_text":"- Patients with mechanical assist devices: extracorporeal membrane oxygenator (ECMO), left ventricular assist device (LVAD), right ventricular assist device (RVAD), intra-aortic balloon pumps (IABP)."}
• {"criterion_text":"- Known severe ventricular dysfunction (left ventricular ejection fraction [LVEF] <30%)"}
• {"criterion_text":"- Post-surgical septic infection."}
• {"criterion_text":"- Clinically significant anemia with hemoglobin values below 100 g/L."}
• {"criterion_text":"- Positive serologies for hepatitis C virus (HCV), hepatitis B virus antigen (HBSAg), human immunodeficiency virus (HIV) or syphilis (by RPR: rapid plasma reagin). This criterion will be evaluated once it has been confirmed that the patient has developed AKI."}
• {"criterion_text":"- Participation in another clinical intervention test"}
• {"criterion_text":"- AKI in the month prior to cardiac surgery."}
• {"criterion_text":"- Patients who have previously undergone renal replacement therapy."}
• {"criterion_text":"- Patients who, due to their clinical condition (hemodynamic instability, oliguria, present or foreseeable volume overload), are expected to start renal replacement therapy within 48 hours after diagnosis of AKI."}
• {"criterion_text":"- Interstitial glomerulonephritis or vasculitis."}
• {"criterion_text":"- Pregnancy."}
• {"criterion_text":"- Breastfeeding women."}
• {"criterion_text":"- History of renal transplant."}
• {"criterion_text":"- Endocarditis."}

Primary endpoints

• {"endpoint_text":"- Renal function recovery time","definition_or_measurement_approach":"Time from AKI diagnosis to recovery of renal function (time-to-event measure as described in main objective)."}
• {"endpoint_text":"- Proportion of patients with no persistently altered creatinine values (>31% of baseline values) 7 days after AKI episode","definition_or_measurement_approach":"Proportion of patients whose creatinine is not persistently altered by >31% compared with baseline at 7 days after the AKI episode."}
• {"endpoint_text":"- Occurrence of adverse events (AEs), serious AEs (SAEs), AEs resulting in discontinuation of study treatment, AEs of special interest","definition_or_measurement_approach":"Assessment and recording of AEs/SAEs and those leading to discontinuation or classified as events of special interest (occurrence counts and descriptions)."}

Secondary endpoints

• {"endpoint_text":"- Reducing the incidence of MAKE ** **MAKE (major adverse kidney events): death, dialysis, or permanent reduction in estimated glomerular filtration rate (CKD-EPI) of >30% of baseline value.","definition_or_measurement_approach":"Occurrence of MAKE defined as death, initiation of dialysis, or permanent reduction in eGFR (CKD-EPI) >30% from baseline."}
• {"endpoint_text":"- Number of patients on renal replacement therapy and duration of therapy","definition_or_measurement_approach":"Count of patients requiring renal replacement therapy and measurement of duration (days) of therapy."}
• {"endpoint_text":"- Duration of ICU admission (days). Duration (days) of hospital stay of the patients","definition_or_measurement_approach":"Measured duration in days of ICU admission and total hospital stay."}
• {"endpoint_text":"- Global survival at 30 days. Global survival at 90 days.","definition_or_measurement_approach":"Survival status assessed at 30 and 90 days post-AKI."}
• {"endpoint_text":"- Global survival at 30 days. Number of patients on dialysis at 30 days. Global survival at 90 days. Number of patients on dialysis at 90 days","definition_or_measurement_approach":"Survival and dialysis status assessed at 30 and 90 days."}
• {"endpoint_text":"- Maximum creatinine values (peak creatinine) recorded during the patients' hospitalisation and time (days) when the maximum peak occurs","definition_or_measurement_approach":"Peak serum creatinine value during hospitalization and day of peak occurrence."}
• {"endpoint_text":"- Improved levels of injury biomarkers in urine","definition_or_measurement_approach":"Measurement of predefined urinary injury biomarkers and assessment of improvement compared to baseline."}
• {"endpoint_text":"- Patients presenting: Surgical wound infections; Respiratory infections during ICU stay","definition_or_measurement_approach":"Occurrence counts of surgical wound infections and respiratory infections during ICU stay."}
• {"endpoint_text":"- Complications related to surgery: Sternotomy; Re-intervention; Circulatory support","definition_or_measurement_approach":"Recording of specified surgery-related complications (sternotomy, re-intervention, need for circulatory support)."}
• {"endpoint_text":"- Unexplained hemodynamic impairment: - Drop in cardiac index to <2.5 L/min/m2 (if previously higher) and/or - Drop in systemic systolic blood pressure >30% or <90 mmHg and/or Increased dose of vasoactive drugs > 30%","definition_or_measurement_approach":"Occurrence of defined hemodynamic impairments: cardiac index drop <2.5 L/min/m2, systolic BP drop >30% or <90 mmHg, or increase in vasoactive drugs dose >30%."}

Spain

Earliest CTIS Part Ii Submission Date

27-05-2024

Latest Decision Or Authorization Date

26-02-2026

Processing Time Days

640

Number Of Sites

3

Number Of Participants

98

Primary sponsor

Full Name

M2rlab S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Contract research organisations

Name

Sermes CRO

Responsibilities

On site monitoring, Statistical analysis, Medical writing, Regulatory expertise, Project management, Safety reporting

Third parties

• {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"product releaser","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"On site monitoring, Statistical analysis, Medical writing, Regulatory expertise, Project management, Safety reporting","organisation_type":"Pharmaceutical company"}