Clinical Research Directory

Predicting Post-Cardiac Surgery Acute Kidney Disease: A Machine Learning Approach

Renal injury after cardiac surgery is one of the common complications with high incidence rate, high risk of death and progression to chronic kidney disease (CKD). Previous evaluations of perioperative renal function mainly focused on acute kidney injury (AKI) related to cardiac surgery within seven days after surgery. The newly proposed concept of acute kidney disease (AKD) in recent years refers to acute or subacute kidney injury lasting seven to ninety days. Research has found that AKD can occur after AKI or in patients without AKI, and the two are both related and independent of each other, possibly indicating different subtypes of kidney injury. AKD is not uncommon and is a more significant predictor of mortality and end-stage kidney disease (ESKD). Therefore, AKD may be an important window for identifying and managing high-risk patients after cardiac surgery. Due to limited research on AKD after cardiac surgery, the risk factors for AKD are currently unclear, and there are no clinically practical and effective risk stratification tools available. This study aims to establish a multimodal perioperative data platform through a retrospective cohort, and use machine learning methods to construct a risk prediction model for AKD after cardiac surgery. The accuracy and stability of the model will be validated in a prospective study cohort, and an online risk prediction and clinical decision-making tool will be developed to help clinicians quickly conduct personalized risk assessments and optimize diagnosis and treatment strategies, thereby improving patient prognosis and reducing medical costs.

Trimethoprim-Sulfamethoxazole (TMP/SMX) Prophylaxis After Acute Kidney Injury to Prevent Post-discharge Infections

Official Title Trimethoprim-Sulfamethoxazole (TMP/SMX) Prophylaxis After Acute Kidney Injury to Prevent Post-discharge Infections: A Randomized, Double-Blind, Placebo-Controlled Trial Brief Summary Acute kidney injury (AKI) is commonly followed by infections after hospital discharge. This randomized, double-blind, placebo-controlled trial will test whether prophylactic TMP/SMX reduces post-discharge infections in adults recently hospitalized with AKI. Participants will be randomized 1:1 to TMP/SMX or matching placebo and followed for 6 months. The primary outcome is the proportion of participants who develop any infection within 90 days after discharge. Secondary outcomes include time to first infection, infection-related hospitalization, mortality, safety/adverse events, and healthcare utilization through 180 days. Detailed Description Adults discharged after an index hospitalization complicated by AKI are at elevated infection risk. This trial evaluates whether short-term TMP/SMX prophylaxis reduces 90-day infections. After consent and eligibility confirmation near discharge, participants are randomized (1:1) to receive TMP/SMX or matching placebo with double-blind masking (participant and outcome assessor). Dosing is standardized per protocol. We will ascertain infections via structured follow-up, medical record review, and adjudication by blinded assessors. Safety monitoring will capture adverse events (e.g., rash, cytopenias, hyperkalemia). Analyses follow intention-to-treat. Study Design * Study Type: Interventional (Clinical Trial) * Primary Purpose: Prevention * Allocation: Randomized (1:1) * Intervention Model: Parallel Assignment * Masking: Double-blind (Participant, Outcomes Assessor) * Estimated Enrollment: 60 patients per group * Study Start Date: December 2025 * Primary Completion Date (Anticipated): January 2027 (last patient reaches 90-day outcome) * Study Completion Date (Anticipated): July 2028 (last patient completes 180-day follow-up) Arms \& Interventions Experimental: TMP/SMX * Intervention: Drug: Trimethoprim-Sulfamethoxazole (TMP/SMX) 160/800 mg tablets every 48 hours * Dosing: One tablet by mouth, Trimethoprim-Sulfamethoxazole (TMP/SMX) 160/800 mg tablets every 48 hours, for 90 days post-discharge. * Other names: cotrimoxazole, sulfamethoxazole-trimethoprim. Bactrim F Placebo Comparator: Placebo * Intervention: Drug: Placebo (matching oral tablet) * Dosing: Matching schedule for 90 days post-discharge. Concomitant care: Allowed per treating clinician. Drug interactions and lab monitoring handled per protocol. Outcome Measures Primary Outcome • Any infection within 90 days after discharge Time Frame: Day 0 (discharge) to Day 90 Measure: Proportion of participants with ≥1 infection, defined by clinical diagnosis requiring documentation (e.g., UTI, pneumonia, SSTI, bloodstream infection) and/or antimicrobial treatment initiation. Secondary Outcomes 1. Time to first infection (days) within 90 days. 2. Infection-related hospitalization within 90 and 180 days. 3. All-cause mortality at 90 and 180 days. 4. Emergency department visits or unplanned readmissions within 180 days. 5. Antibiotic-related adverse events (rash, cytopenia, creatinine rise ≥0.3 mg/dL, hyperkalemia ≥5.5 mmol/L) through 180 days. 6. C. difficile infection within 180 days. 7. Recurrent AKI (KDIGO criteria) within 180 days. 8. Medication adherence (pill counts and/or self-report) over 90 days. 9. Major adverse kidney events over 90 days. Eligibility Criteria Inclusion Criteria * Age ≥18 years. * Index hospitalization complicated by AKI (KDIGO criteria) prior to discharge. * Planned discharge to community/rehabilitation with capacity for follow-up. * Ability to provide informed consent. Exclusion Criteria * Known allergy to sulfonamides or TMP/SMX. * Pregnancy or breastfeeding. * Severe hepatic disease (e.g., Child-Pugh C). * Severe cytopenia (e.g., ANC \<1.0×10⁹/L or platelets \<50×10⁹/L). * Baseline hyperkalemia (\>5.5 mmol/L) not correctable prior to randomization. * Concomitant medications with high-risk interactions not amenable to dose/monitoring (per protocol). * Current systemic antimicrobial therapy planned for \>14 days after discharge (prophylaxis not indicated). * Inability to adhere to study procedures or follow-up. Contacts/Locations * Lead Sponsor / Responsible Party: Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara, servicio de Nefrología * Principal Investigator: Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara, servicio de Nefrología, 3313299609 * Study Locations: Hospital Civil de Guadalajara, servicio de Nefrología, Hospital 278, colonia el Retiro. Guadalajara. Jalisco. Ethics and Oversight * Conducted in accordance with the Declaration of Helsinki and ICH-GCP. * IRB/Ethics approval: Comité de etica en investigacion, Protocol CEI 214/25, Approval : October 16, 2025. * Written informed consent obtained from all participants prior to any study procedures. * Data

AST-120 (Kremezin®) for the Renal Protection and Attenuation of Decline in Acute Kidney Disease

The primary goal of this clinical trial is to evaluate the efficacy of AST-120 (Kremezin®) in combination with standard care in reducing the levels of protein-bound uremic toxins (PBUTs), specifically indoxyl sulfate (IS) and p-cresyl sulfate (p-CS), in patients with acute kidney disease (AKD). The trial aims to assess whether AST-120 can prevent further renal deterioration and slow the progression from AKD to chronic kidney disease (CKD) by mitigating the accumulation of PBUTs. Additionally, the study will investigate the potential of AST-120 to reduce the risk of CKD-associated complications, including cardiovascular disease, by reducing PBUT levels in AKD patients.

Impact of Different CRRT Modalities, Dosing Strategies, and Timing on Kidney Recovery and Prolonged Kidney Dysfunction

KARMA study is a hospital-based research study looking at how different ways of delivering kidney support therapy (CRRT) affect patients who are critically ill. In some cases, the kidneys may temporarily stop working in very sick patients, and machines are used to filter the blood. This study is exploring whether the way the investigators use these machines - how early to start, how much treatment to give, and what type to choose - makes a difference in how well the kidneys recover. By learning from many hospitals and hundreds of patients, KARMA hopes to improve treatment choices and help patients regain their kidney function faster.

Demethylating Agent Azacitidine on Prevention of Acute Kidney Injury-chronic Kidney Disease Continuum

Acute kidney injury (AKI) is increasing worldwide in recent years and is a major risk factor of chronic kidney disease (CKD). AKI, acute kidney disease (AKD) and CKD form a continuum whereby initial kidney injury leads to ongoing renal injury and eventually end-stage renal disease if no effective treatment is applied. Nevertheless, there are no useful pharmacotherapies approved clinically for the treatment of AKI and subsequent CKD. Previous studies of the investigators have confirmed that pericytes are the primary cell source of scar-producing myofibroblasts. Furthermore, the investigators had demonstrated that significant epigenetic modification in transcriptome analysis of pericytes develops in different stage of AKI-CKD continuum. These epigenetic memory made pericytes obtain proliferative and pro-fibrotic phenotypes in activated status and persist in inactivated status. Demethylation by azacitidine prevented AKI-CKD transition, and attenuated fibrogenesis induced by a second adenine-AKI. Azacitidine has been approved in the United States Food and Drug Administration and European Union for treatment of adult acute myeloid leukemia (AML), particularly recommended front-line treatment for older patients with acute myeloid leukemia who are not candidates for intensive treatment regimens. Dosage of azacitidine in clinical trial is calculated according to previous study and is lower than chemotherapeutic dose. Low dose azacitidine has demethylation effect and less cytotoxicity. CSA-AKI is the second commonest cause of AKI in ICU. The investigators plan to initiate a double-blind randomized controlled trial (RCT) to recruit CSA-AKI patients. The patients will be divided as azacitidine group and placebo group. Patients in azacitidine group will receive three doses of low dose azacitidine in one week when AKI is diagnosed. After that, the investigators will follow up their renal function and urine protein every three month. Primary composite outcomes include a decline of at least 50% in the estimated GFR, an increase of urine protein-creatinine ratio (UPCR) over 1000 mg/g, and the development of end stage renal disease (ESRD). Secondary outcome is overall mortality.