NCT05001503 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Howitt SH, Grant SW, Caiado C, Carlson E, Kwon D, Dimarakis I, Malagon I, McCollum C
The KDIGO acute kidney injury guidelines for cardiac surgery patients in critical care: a validation study. BMC Nephrol. 2018 Jun 25;19(1):149. doi: 10.1186/s12882-018-0946-x.
Howitt SH, Oakley J, Caiado C, Goldstein M, Malagon I, McCollum C, Grant SW
A Novel Patient-Specific Model for Predicting Severe Oliguria; Development and Comparison With Kidney Disease: Improving Global Outcomes Acute Kidney Injury Classification. Crit Care Med. 2020 Jan;48(1):e18-e25. doi: 10.1097/CCM.0000000000004074.

Pivotal Phase, Randomised Controlled Trial to Demonstrate a Reduction in the Number of Oliguria Events in Patients Being Managed in a Critical Care Unit, Following Cardiac Surgery, When a Novel Oliguria Prediction Tool (STABILITY UO) is Used to Identify Patients at Risk, Compared to Standard of Care.

Details for clinical trial NCT05001503

Clinical trial NCT05001503 - References