A clinical trial is being conducted to evaluate the efficacy of two different doses of vitamin D3 in critically ill patients undergoing continuous renal replacement therapy (CRRT). The study, titled "Comparison of two doses of vitamin D3 in critically ill patients undergoing continuous renal replacement therapy," aims to determine the optimal dosage for improving patient outcomes in this vulnerable population.
Study Design and Patient Monitoring
The trial involves a series of six visits over a period of approximately 90 to 104 days. During the initial screening visit, investigators identify eligible patients in the Intensive Care Units (ICUs) and obtain informed consent. Comprehensive medical histories are reviewed, and baseline data, including demographics, comorbidities, and concomitant treatments, are collected. Vital signs such as blood pressure and heart rate are assessed, and a physical examination is performed, covering various systems including abdominal cavity, respiratory, nervous, cardiovascular, and genitourinary systems. CRRT parameters, including blood flow rate, pre-blood pump flow rate (PBP), dialysate flow rate, replacement fluid flow rate, net fluid removal, CRRT dose, and CRRT method, are also recorded.
Blood tests are conducted to measure complete blood count, clinical chemistry (sodium, potassium, total calcium, chloride, phosphorus, urea, creatinine, and bilirubin), clotting parameters (INR, APTT), serum 25(OH)D3, and PTH levels. Women of childbearing potential undergo a serum pregnancy test. Abdominal ultrasound or computed tomography (CT) scans are evaluated to rule out kidney stones. SOFA and SAPS II scores are calculated to assess the severity of illness. Imaging scans and laboratory tests performed within specified timeframes before the first visit are considered, with the investigator determining whether repetition is necessary based on the patient’s clinical status. Adverse events are also monitored during the screening visit.
Vitamin D3 Administration and Follow-Up
Within 24 hours of the initial visit, a second visit is conducted to reassess inclusion and exclusion criteria, re-verify informed consent, and randomize patients to receive one of the two vitamin D3 doses. The assigned dose is administered enterally via a nasogastric tube or orally if the patient can take oral medication. The calculated dose of vitamin D3 is given with water at a 1:1 ratio. Adverse events and concomitant treatments are monitored during this visit.
Subsequent visits on days 3, 7, and 28 (± 4 days) involve repeated measurements of blood pressure and heart rate, physical examinations, collection of CRRT parameters, and blood tests to monitor clinical chemistry, clotting parameters, serum 25(OH)D3, and PTH levels. SOFA scores are recalculated, and data on gastric residual volume (GRV) and the duration of CRRT use are collected. Adverse events and concomitant treatments continue to be monitored.
A final visit between days 90 and 104 assesses the patient’s survival status, ICU treatment duration, catecholamine intake, and duration of catecholamine use. This visit can occur at the hospital or via telephone. Throughout the study, efforts are made to retain participants and complete follow-up assessments, with emphasis on the importance of follow-up and the collection of outcome data. Patients can withdraw consent at any time, and their data will be handled according to their preferences.
Data Management and Confidentiality
The study utilizes electronic case report forms (eCRFs) for data entry, ensuring that data are based on patient source documentation and are accurate, complete, and up-to-date. The eCRF is owned by the sponsor and is not accessible to third parties without authorization. Adverse events and medical/surgical history are classified using the Medical Dictionary for Regulatory Activities (MedDRA), and concomitant medications are recorded using codes from the WHO Model List of Essential Medicines based on the Anatomical Therapeutic Chemical Classification System. Data are reviewed, verified, signed, and blocked, and the database is locked. Investigators confirm the completeness of each patient’s data in the eCRF.
All patient-identifying records are kept confidential, with study subjects identified by unique ID numbers. Informed consent forms explain that sponsor representatives, independent ethics committees (IECs), or regulatory authorities may access medical records for verification purposes, with strict confidentiality maintained. Patient identities are not disclosed in any publications resulting from the study.
