Table of contents
- Trial overview
- Influenza and immune response study
- Intensive care and filter clotting study
- Other authorised studies in the source data
- Trial design, phases, and endpoints
- Patient groups and participation
- Key terms explained
Trial overview
The source data includes four clinical trials, but only one trial record names Sodium Citrate directly in the request context; the provided trial records themselves focus on different study interventions and settings. The article therefore summarizes the clinical trials exactly as described in the source data, without adding outside details.[1]
These studies are interventional, which means researchers are testing a treatment, procedure, or care strategy and then measuring what happens in the study group.[1] The trials cover very different areas of care, including influenza, intensive care, cardiac surgery, and colorectal cancer screening.[1]
Influenza and immune response study
NCT03323112 is a completed Phase 3 trial in health care personnel, with enrollment of 1500 people.[1] The study looked at influenza and immunity against influenza, and it used pre-vaccination and post-vaccination serum samples to assess antibody responses.[1]
The main outcome was humoral immunity, which means the antibody response in the blood.[1] The study measured antibodies against influenza virus strains included in current and past vaccines, as well as circulating strains, using hemagglutination inhibition testing and sometimes microneutralization or neutralization tests.[1]
This trial was designed to understand whether vaccination produced measurable immune responses in this workforce group, rather than to study long-term illness outcomes.[1]
Intensive care and filter clotting study
2024-511897-64-00 is a completed multicenter randomized controlled non-inferiority study in adult intensive care patients who had an indication for extracorporeal purification during their stay.[1] The study enrolled 412 patients and used a low-intervention design.[1]
The primary endpoint was the incidence of filter thrombosis, meaning clotting inside the filter used during treatment.[1] The study aimed to show that a higher post-filter calcium target, between 0.35 and 0.45 mmol/L, could provide anticoagulation that is comparable to a lower target of 0.25 to 0.35 mmol/L during regional citrate anticoagulation in intensive care.[1]
In simple terms, this trial compared two calcium target ranges to see whether the circuit could stay open and work well without more clotting.[1]
Other authorised studies in the source data
2024-511948-42-00 is an authorised Phase 3 trial in patients undergoing major cardiac surgery with extracorporeal circulation and prolonged aortic clamping times.[1] The study plans to compare Custodiol crystalloid cardioplegia with Buckberg blood cardioplegia and to test whether Custodiol is non-inferior.[1]
The primary outcome is a composite event made up of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure at 90 days after the intervention.[1] A composite outcome means several important events are grouped together into one main result.[1]
2025-523748-11-00 is an authorised Phase 3 trial for colorectal cancer early detection in 818 people.[1] It compares Clensia and CitraFleet in a randomized parallel comparative design, and the primary outcome is adenoma detection rate during screening colonoscopy.[1]
Adenoma detection rate is the share of patients in whom at least one adenoma is found, and adenomas are growths that can be important in cancer screening.[1]
Trial design, phases, and endpoints
Most of the trials in the source data are Phase 3 studies, which usually means larger studies that look at how well a strategy works in real patient care.[1] One study is labeled low intervention, which suggests the study mainly observes a care approach with limited added research burden.[1]
The endpoints differ by condition. In the influenza trial, the endpoint is antibody response; in the intensive care trial, it is filter thrombosis; in the cardiac surgery trial, it is a composite of major postoperative events; and in the colonoscopy trial, it is adenoma detection rate.[1]
These endpoints show that the trials are not studying one single disease area, but instead are testing different clinical questions in separate patient groups.[1]
Patient groups and participation
The studies include health care personnel, adult intensive care patients, patients undergoing major cardiac surgery, and adults having colorectal cancer screening colonoscopy.[1] Each trial has its own target population, so participation depends on the condition being studied and the setting of care.[1]
Enrollment ranges from 412 to 1500 participants in the source data, which shows that the studies are designed with different sample sizes based on their goals and methods.[1]
Key terms explained
Randomized means people are assigned to study groups by chance, which helps make the comparison fair.[1]
Non-inferiority means the study is trying to show that one treatment is not meaningfully worse than another standard treatment.[1]
Serum samples are blood samples used to measure substances such as antibodies.[1]
Extracorporeal purification means blood is treated outside the body using a machine.[1]
Colonoscopy is a test where a doctor looks inside the colon using a flexible camera tube.[1]
