Several clinical trials have evaluated PMSF-associated parameters and outcomes in surgical and critical care settings, focusing on conditions such as cardiac surgery, valve replacement, coronary artery bypass, peri-operative fluid management, and sepsis. Sponsored predominantly by academic and hospital centers—including University Hospital Strasbourg and St George's University of London—these studies utilize non-interventional or not applicable phase classifications, with recruitment statuses ranging from completed to unknown. Overall, this body of research highlights hemodynamic monitoring and fluid responsiveness in critical care and cardiovascular surgery.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04062786 | Unknown status | Scheduled Heart Surgery|Valve Replacement|Coronary Artery Bypass |
University Hospital Strasbourg France |
2019-02-21 | -- |
| NCT03300323 | Unknown status | Peri-operative Fluid Management |
St George''s Healthcare NHS Trust |
2017-10 | Not Applicable |
| NCT02447042 | COMPLETED | Sepsis |
St George's, University of London |
2014-11 | |
| NCT02569008 | COMPLETED | Post Cardiac Surgery |
St George's, University of London |
2014-01 | |
| NCT02569008 | Completed | Post Cardiac Surgery |
St George''s University of London |
2014-01 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).