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Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive Respiratory Support (SEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial

Study acronym: SEED-NIRS
StatusNot Yet Recruiting
PhasePhase 4
Started2026-09-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from The First Affiliated Hospital with Nanjing Medical University

Amendment history

2026-09-01
Study Identification, Study Status, Study Design, Outcome Measures v8
Primary endpoint(s) modified1 entry, revised
WasA hierarchical composite endpoint within 14 days, including intubation or tracheostomy, delirium duration, and agitation duration
NowA hierarchical composite endpoint within 7 days, including intubation or tracheostomy, delirium duration, and agitation duration
Start date2026-08-01→2026-09-28
Enrollment target388→356
Secondary endpoints8 entries, revised
The number of ventilator-free and/or delirium free days (the number of days without a positive CAM-ICU) at day 147 Open-label rescue of Antipsychotic Medications (e.g., haloperidol, olanzapine) in the first 147 days. All-cause mortality at day 1428
Study titlerevised
[...] lirium in ICU Patients on Non-Invasive Respiratory Support (ESSENTIALSEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial
2026-08-06
Study Identification, Study Status v7
Study titlerevised
[...] lirium in ICU Patients on Non-Invasive Respiratory Support (SEED-NIRSESSENTIAL Trial): Study Protocol of a Randomized Controlled Trial
2026-06-30
Study Identification, Study Status, Oversight, Outcome Measures v6
Study title+63 characters
EfficacySafety and SafetyEfficacy of Esketamine Combined With- Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive ICURespiratory Patients With Hyperactive DeliriumSupport (ESSENTIALSEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial
2026-06-23
Study Status, Outcome Measures v5
Start date2026-07-01→2026-08-01
2026-06-07
Study Status, Outcome Measures v4
Primary endpoint(s) modified1 entry, revised
WasA hierarchical composite endpoint within 28 days, including intubation or tracheostomy, delirium duration, and agitation duration
NowA hierarchical composite endpoint within 14 days, including intubation or tracheostomy, delirium duration, and agitation duration
Secondary endpoints8 entries, revised
The number of ventilator-free and/or delirium free days (the number of days without a positive CAM-ICU) at day 2814 Open-label rescue of Antipsychotic Medications (e.g., haloperidol, olanzapine) in the first 2814 days. All-cause mortality at day 7 and day 2814
2026-05-27
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v3
Primary endpoint(s) modified1 entry, revised
WasDuration of Delirium (Time with positive CAM-ICU)
NowA hierarchical composite endpoint within 28 days, including intubation or tracheostomy, delirium duration, and agitation duration
Enrollment increased: 132 → 388 participants
Start date2026-06-02→2026-07-01
Eligibility criteria+2 characters
Inclusion Criteria: Age ≥18 years and ≤9080 years at the time of randomization; Hospitalized in the Intensive Care Unit (ICU) or receiving ICU-level care (with an expected ICU stay >24 hours); Patients with hyperactive delirium: meeting criteria for Confusion Assessment Method for the ICU (CAM-ICU)[19] positivity (i.e., acute onset or fluctuating course plus in [...] ized thinking or altered level of consciousness) and having aagitation which is diagnosed if the Richmond Agitation-Sedation Scale (RASS) score[20] >is superior or equal to +1. (The RASS and the Confusion Assessment Method for the ICU (C [...] [...]
Secondary endpoints9 to 8 entries
DurationThe number of Agitationventilator-free and/or delirium free days (Timethe with RASS > +1) Endotracheal Intubation and Mechanical Ventilation Rate 28-day Mortality Rate ROX Index and SpO₂/FiO₂ Ratio Lengthnumber of days without a positive CAM-ICU) Stayat day 28 UseDelirium recurrence rate Open-label rescue of Antipsychotic Medications (e.g., haloperidol, olanzapine) in the first 28 days. The length of ICU stay All-cause mortality at day 7 and day 28
Study title-1 characters
An Exploratory Study of the Efficacy and Safety of Esketamine andCombined With Dexmedetomidine in Non-IntubatedInvasive ICU Patients With Hyperactive Delirium (ESSENTIAL Trial): Protocol of a Randomized Controlled Trial
2026-04-08
Study Identification, Study Status, Study Design v2
Enrollment increased: 86 → 132 participants
Start date2026-02-22→2026-06-02
Study title+43 characters
[...] dine in Non-Intubated ICU Patients With Hyperactive Delirium: Protocol of a Randomized Controlled Trial
2026-02-26
Study Status, Outcome Measures v1
Secondary endpoints9 entries, revised
Pain Assessment using the Critical-Care Pain Observation Tool (CPOT) or Visual AnalogEnhanced Numeric Rating Scale (VAS（NRS-V)
2026-01-28
Original filing
This investigator-initiated, randomized, controlled, single-blind, superiority trial aims to assess the efficacy and safety of esketamine combined with dexmedetomidine for the management of agitation or delirium in intensive care unit (ICU) patients receiving non-invasive respiratory support. The primary endpoint is a clinically prioritized hierarchical composite endpoint within 28 days, including intubation or tracheostomy, delirium duration, and agitation duration.
Trial Details
NCT Number NCT07377981
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Dexmedetomidine, Ketamine, Analgesia, Respiratory Therapy, Intensive Care Units (ICUs), Agitation, Sedation and Analgesia
Enrollment 356 participants
Start Date 2026-09-28
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-03