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Can a Low-Dose ketamine infusion outsmart delirium in heart failure?

NCT ID NCT07781462

Disease control Sponsor: Alexandria University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests whether a low-dose ketamine infusion can treat delirium in intensive care unit (ICU) patients with acute heart failure, comparing it to the standard sedative dexmedetomidine. Delirium—a sudden state of confusion and altered attention—is common in these patients and linked to longer hospital stays and worse outcomes. The study will enroll 150 adults with confirmed acute heart failure and active delirium, giving each a continuous infusion of one drug to achieve light sedation. The main goal is to see which drug resolves delirium faster and with fewer side effects, especially protecting heart function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low-dose ketamine infusion or dexmedetomidine infusion
What this could lead to
If successful, this could identify a safer, more effective sedation strategy to treat delirium in acute heart failure patients, potentially reducing ICU stays and improving recovery.
What could go wrong
This is a single-center trial, and results may not apply broadly. Both drugs carry risks—ketamine may cause psychotropic effects, while dexmedetomidine can lower blood pressure and heart rate, which is risky in heart failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years. 2. Confirmed diagnosis of acute heart failure according to established clinical and echocardiographic criteria. 3. Confirmed active ICU delirium at enrollment, as defined by: * Positive CAM-ICU or ICDSC (score ≥4) at screening AND * RASS ≥ +1 (agitation) or RASS ≤ -1 (hypoactive) indicating a motoric subtype. 4. Informed consent obtained from the patient or legal representative. Exclusion Criteria: 1. Primary neurological events (e.g., stroke, seizure, traumatic brain injury) as cause of altered mental status. 2. Severe hepatic dysfunction (e.g., Child-Pugh Class C) or renal impairment (eGFR \< 30 mL/min/1.73m²). 3. Known hypersensitivity or contraindication to ketamine or dexmedetomidine. 4. Current or recent (within 48 hours) use of antipsychotics, benzodiazepines, or other sedatives. 5. History of psychosis, schizophrenia, or substance use disorder. 6. Pregnant or lactating women. 7. Patients requiring deep sedation or neuromuscular blockade for clinical reasons.

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Conditions

The condition(s) this trial relates to.

delirium heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute heart failure (AHF) Delirium in intensive care unit

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alexandria Main University Hospital (AMUH)

    Alexandria, 21500, Egypt

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