Acute kidney injury
Conditions
Interventions
Group 1:MgSO4 + compound amino acids
Group 2:MgSO4 + Normal saline
Group 3:Normal saline + compound amino acids
Group 4:Normal saline + Normal saline
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 years or older; 2. Subjects must be undergoing surgery involving cardiopulmonary bypass, including one of the following: coronary artery bypass grafting (CABG); aortic valve replacement/repair, with or without procedures on the aortic root, ascending aorta, and aortic arch; isolated mitral, tricuspid, or pulmonary valve replacement or repair; multiple heart valve replacements; CABG combined with aortic, mitral, tricuspid, or pulmonary valve replacement/repair; 3. Subjects must be at risk of developing acute kidney injury (AKI) before surgery, meeting at least one of the following risk factors: CABG combined with one or more heart valve surgeries with at least 1 AKI risk factor; multiple heart valve surgeries with at least 1 AKI risk factor; CABG or aortic valve surgery combined with aortic root, ascending aorta, and aortic arch surgery (excluding aortic dissection) with at least 1 AKI risk factor; isolated CABG or single valve surgery with at least 2 AKI risk factors; 4. Mg2+ concentration < 1 mmol/L; 5. Subjects must be able to understand the informed consent form, have the capacity to sign it, and be willing and able to comply with the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1.Use of a ventricular assist device, intra-aortic balloon pump, or other cardiac device within 7 days prior to surgery; 2.Cardiopulmonary resuscitation within 14 days prior to surgery; 3.Known unstable renal function (creatinine increase >=0.3 mg/dL) or renal dysfunction (eGFR 2× upper limit of normal, or bilirubin > 1.5× upper limit of normal) prior to surgery; 8.Requirement for emergency surgery or surgery performed under life-threatening conditions; 9.Participation in any other clinical trial (including drug or device trials) within 30 days prior to screening or within five half-lives of the investigational product (whichever is longer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who completed MgSO4, compound amino acid, or normal saline infusion;Incidence of postoperative AKI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality;AKI KDIGO classification;Postoperative days of hospital stay;Serum Creatinine (SCr);Urine volume;Serum magnesium concentration;CRRT utilization rate;Non-AKI complications;Mechanical ventilation time;Postoperative days of ICU stay; | — |
Countries
China
Contacts
Public ContactSun Bin
Xuzhou Central Hospital
Outcome results
None listed