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Not Yet Recruiting NCT05748301

AI Clinician XP2 - A Study of the AI Clinician Running in Real Time in the ICU

Conditions: Sepsis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 64
Sponsor: Imperial College London

Location: United Kingdom

Summary

The cornerstone of sepsis resuscitation is the administration of intravenous fluids (IVF) and/or vasopressors (drugs that squeeze the blood vessels to increase blood pressure) to maintain blood flow to prevent organ failure. However, there is huge uncertainty around the individual dosing of these drugs in an individual patient, partially due to high sepsis heterogeneity. The current guidelines provide recommendations at a population-level but fail to individualise the decisions. Wrong decisions lead to poorer outcomes and increased ICU-resource use. A tool to personalise these medications could improve patient survival.The investigators have developed a new method to automatically and continuously review and recommend the correct dose of these medications to doctors, which was created using artificial intelligence (AI) techniques applied to large medical databases. The method used is called reinforcement learning, and we call the technology the "AI Clinician".In the AI Clinician XP1, the investigators tested the safety of the AI Clinician when running in "shadow mode", i.e. in pseudonymised batches of patient data presented to off-duty ICU clinicians. This enabled the investigators to 1) develop methods and software to connect to real-time electronic health records (EHR); 2) check the safety of the algorithm when used in a contemporary UK ICU patient cohort.In XP2, the AI Clinician will be running in real-time on dedicated computers at the bedside of actual patients in 4 ICUs across 2 NHS Trusts (Three ICUs at ICHT and one ICU at UCLH).

Eligibility Criteria

Inclusion Criteria:For patients:Adult > 18yrAdmitted to an ICU in a participating centreWith early (within 24 of onset) sepsis (as defined by the sepsis-3 definition)For full escalation (no ceiling of care, e.g. patient "not for vasopressors")Expected to survive more than 24hHas not opted-out for use of their data for research (NHS and NHS-X website)For clinician participants:- ICU doctors at the senior registrar, ICU fellow or consultant levelExclusion Criteria:For patients:Not for full active care, e.g. not for vasopressorsNot expected to survive more than 24hrElective surgical admission (these patients are regularly on antibiotics but given as a prophylaxis, with no sepsis)Opted-out for use of their data for research (NHS and NHS-X website)For clinician participants:- Declined participation

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05748301). StuddyBuddy aggregates publicly available trial information.