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NCT02899156 · ClinicalTrials.gov registry record · Phase 4

Flumazenil for Hypoactive Delirium Secondary to Benzodiazepine Exposure

A Phase 4 study, sponsored by University of California, Davis.

Terminated
Registry status
Phase 4
Development phase
22
Enrollment target

NCT02899156: Clinical Trial Phase 4 study, sponsored by University of California, Davis.

NCT02899156 is a Phase 4 study that was terminated before completion, run by University of California, Davis. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02899156, a Phase 4 study, was terminated before completion, sponsored by University of California, Davis.

TERMINATED
Registry status
Phase 4
Development phase
22 participants
Enrollment target

Study Summary

Delirium within the intensive care unit (ICU) is associated with poor outcomes such as increased mortality, ICU and hospital length of stay (LOS), and time on mechanical ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of delirium. Reversal of hypoactive delirium represents a potential opportunity for reducing duration of delirium and subsequent complications. This is a single-center randomized, double-blind, placebo-controlled study of critically ill adult patients with benzodiazepine-associated hypoactive delirium. The hypothesis is that flumazenil continuous infusion may reverse hypoactive delirium associated with BZD exposure and thereby reduce duration of delirium and ICU LOS.

Primary Outcome

Defined by the number of days in the 14-day period after randomization that the patient was alive and not delirious (i.e. CAM-ICU negative). Zero delirium-free days will be observed for patients that die within the 14-day period.

Interventions

  • DRUG Placebo
  • DRUG Flumazenil

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2016-03
Est. Completion 2019-04-16
Phase Phase 4
University of California, Davis

657 total trials

Why NCT02899156 stopped before completion

NCT02899156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02899156 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02899156 about?

NCT02899156 is a clinical study titled "Flumazenil for Hypoactive Delirium Secondary to Benzodiazepine Exposure". Delirium within the intensive care unit (ICU) is associated with poor outcomes such as increased mortality, ICU and hospital length of stay (LOS), and time on mechanical ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of delirium. Reversal of hypoactive delir...

What is the current status of trial NCT02899156?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2016-03. Estimated completion is 2019-04-16.

What interventions are being tested in trial NCT02899156?

The interventions under investigation include: Placebo (DRUG), Flumazenil (DRUG).

Who is sponsoring clinical trial NCT02899156?

This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02899156's enrollment target sits among peer trials

22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02899156, the US trial registry maintained by the National Library of Medicine. NCT02899156 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.