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Delirium in Intensive Care UnitPhase 4NCT07781462

Intravenous Infusion of Low Dose Ketamine Versus Dexmedetomedine for Delirium Treatment in Acute Heart Failure

A Phase 4 study testing Low dose ketamine infusion and Dexmedetomidine infusion in people with Delirium in Intensive Care Unit and Acute Heart Failure (AHF), run by Alexandria University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Delirium is an acute, fluctuating disturbance in attention and cognition that commonly complicates the course of critically ill patients, particularly those admitted with acute heart failure (AHF). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Low dose ketamine infusion and Dexmedetomidine infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteEgypt
Study dates
Sep 2026to Sep 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Confirmed diagnosis of acute heart failure according to established clinical and echocardiographic criteria.
  • 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.
  • Informed consent obtained from the patient or legal representative.

Who cannot join

  • Primary neurological events (e.g., stroke, seizure, traumatic brain injury) as cause of altered mental status.
  • Severe hepatic dysfunction (e.g., Child-Pugh Class C) or renal impairment (eGFR < 30 mL/min/1.73m²).
  • Known hypersensitivity or contraindication to ketamine or dexmedetomidine.
  • Current or recent (within 48 hours) use of antipsychotics, benzodiazepines, or other sedatives.
  • History of psychosis, schizophrenia, or substance use disorder.
  • Pregnant or lactating women.
  • Patients requiring deep sedation or neuromuscular blockade for clinical reasons.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nada H Abd El-Rahim, PharmD contact

01008328380

gs-nada.hesham@alexu.edu.eg

Noha A. Hamdy, PhD contact

01005182151

noha.alaaeldine@alexu.edu.eg

Egypt1 site
  • Alexandria Main University Hospital (AMUH)

    Alexandria, 21500

Other trials in Egypt

About this study

Delirium is an acute, fluctuating disturbance in attention and cognition that commonly complicates the course of critically ill patients, particularly those admitted with acute heart failure (AHF). Its occurrence in the intensive care unit (ICU) is associated with prolonged mechanical ventilation, longer ICU and hospital stays, increased morbidity and mortality, and substantial healthcare costs. In patients with AHF, the risk of delirium is amplified by factors such as cerebral hypoperfusion, systemic inflammation, sedative exposure, and multi-organ dysfunction. Therefore, effective prevention and early management of delirium in this population are critical to improving outcomes.

Dexmedetomidine, a selective α2-adrenoceptor agonist, has gained wide use in ICU sedation due to its anxiolytic and analgesic properties and minimal respiratory depression. Several randomized controlled trials and meta-analyses have demonstrated that dexmedetomidine-based sedation reduces the incidence and duration of delirium compared with traditional sedatives such as benzodiazepines or propofol. However, its use in AHF patients may be limited by dose-dependent bradycardia and hypotension, potentially compromising hemodynamic stability in an already fragile population.

Read more

Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, possesses unique properties that may offer an alternative approach to delirium prevention. At subanesthetic (low) doses, ketamine provides analgesia, maintains respiratory drive, and exerts sympathomimetic effects that support blood pressure and cardiac output-features that may be advantageous in AHF. Emerging evidence from cardiac surgery and critical care studies suggests that low-dose ketamine infusion might reduce delirium incidence through anti-inflammatory and neuroprotective mechanisms, although data remain limited and heterogeneous.

Given the hemodynamic fragility of AHF patients and the need for sedatives that balance safety and delirium treatment, a direct comparison between low-dose ketamine and dexmedetomidine is warranted. This study aims to evaluate and compare the efficacy and safety of these two agents in treating delirium among AHF patients admitted to the ICU. By addressing this gap, the study seeks to identify a sedation strategy that optimizes cognitive and hemodynamic outcomes in this high-risk population.

Read the detailed description

Delirium is a serious cognitive disturbance marked by fluctuating levels of consciousness, impaired attention, altered perception, and disruptions in memory and cognitive function. It affects roughly 18% to 25% of patients in hospitals, with higher incidence rates seen in critically ill individuals. Delirium is both prevalent and associated with a substantial healthcare burden. While 30% to 40% of cases are preventable, its occurrence leads to greater disability, functional decline, higher morbidity and mortality rates, and increased healthcare expenses, making it a major public health concern. Delirium and heart failure (HF) are closely linked, especially among older adults and critically ill patients. The relationship is bidirectional and multifactorial, with heart failure increasing the risk of delirium, and delirium worsening heart failure outcomes.

Heart failure (HF) is a well-established independent risk factor for delirium. Some studies have observed increased prevalence of delirium among nursing home residents which was associated with a 3-fold increase in mortality within 60 days. Another study reported that HF independently predicts postoperative delirium, which is linked to higher hospital mortality and extended hospital stays. One more study, studying patients with congestive HF, found that delirium was independently associated with higher rates of 30- and 90-day readmissions as well as increased short-term mortality. Delirium in these patients was also related to elevated heart rate, increased serum B-type natriuretic peptide, and the presence of basal rales, suggesting that activation of the renin-angiotensin-aldosterone system may contribute to impaired cerebral metabolism and perfusion, partially accounting for its occurrence. Heart failure can precipitate delirium through multiple mechanisms including cerebral hypoperfusion due to reduced cardiac output, systemic inflammation with elevated cytokines disrupting blood-brain barrier function, hypoxia from pulmonary congestion and low oxygen saturation, electrolyte and metabolic disturbances (e.g., hyponatremia, uremia), medication effects, including diuretics, and antiarrhythmics. All these mechanisms are supported by clinical and experimental studies.

On the other hand, delirium has a profound impact on patients with heart failure (HF), significantly worsening clinical outcomes and quality of life. Evidence shows that delirium is associated with a marked increase in mortality, with a recent meta-analysis demonstrating nearly doubled in-hospital mortality, as well as increased 90-day and 1-year mortality among HF patients. It also contributes to a fourfold higher risk of 30-day hospital readmission, often driven by poor medication adherence, cognitive impairment, and functional decline. In acute decompensated HF, delirium is linked to longer hospital stays, prolonged ICU admissions, and higher healthcare costs due to complications and the need for extended care. Beyond hospitalization, delirium impairs functional recovery, as affected patients show reduced improvement in activities of daily living (ADLs) and a greater likelihood of long-term dependence. Collectively, delirium represents a major determinant of poor prognosis in HF and underscores the importance of early recognition, prevention, and multidisciplinary management.

Management of delirium in patients with heart failure involves both preventive and therapeutic strategies aimed at minimizing risk factors, reducing incidence, and improving outcomes. Prevention focuses on early identification of high-risk individuals through standardized screening tools such as the Confusion Assessment Method for the ICU (CAM-ICU) and the Intensive Care Delirium Screening Checklist (ICDSC). Non-pharmacological measures remain the cornerstone, including orientation protocols, sleep hygiene promotion, early mobilization, ensuring adequate hydration and nutrition, correction of electrolyte imbalances, and minimizing polypharmacy, particularly sedatives and anticholinergic drugs. The use of structured care bundles such as the ABCDEF bundle (Assess pain, Both spontaneous awakening and breathing trials, Choice of sedation, Delirium monitoring, Early mobility, and Family engagement) has demonstrated significant reductions in delirium incidence and improved survival in critically ill patients, including those with cardiac disease.

Treatment is initiated once delirium is diagnosed and includes both supportive care and targeted interventions. Addressing underlying precipitants such as hypoxia, infection, metabolic disturbances, or medication effects is essential. Non-pharmacological approaches should be prioritized, with environmental optimization (adequate lighting, noise reduction, frequent reorientation) playing a crucial role. Pharmacological therapy is generally reserved for severe cases associated with agitation or risk of harm. Low-dose antipsychotics such as haloperidol or atypical agents like quetiapine may be considered, though caution is needed in heart failure due to potential QT prolongation and arrhythmogenic risk. Dexmedetomidine, an α2-adrenergic agonist, has shown promise in reducing delirium duration and maintaining hemodynamic stability compared with benzodiazepines, making it a suitable option in the ICU setting. Emerging evidence also suggests that low-dose ketamine may play a role in delirium treatment particularly in patients with acute heart failure, though further research is warranted. A multidisciplinary approach integrating cardiology, intensive care, clinical pharmacy, and nursing teams is critical for optimizing prevention and treatment strategies in this vulnerable population.

Being tested
Low dose ketamine infusion, Dexmedetomidine infusion
Keywords
Ketamine, Dexmedetomedine, Delirium, Treatment, Acute Heart Failure, Intravenous Infusion, Low-dose Ketamine, Heart Failure
Medical subject headings
Delirium, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose ketamine infusionDrug

    Patients will receive an intravenous infusion of ketamine at a dose of 0.2 - 0.5 mg/kg/hour, titrated to achieve light sedation (RASS -2 to 0). No bolus dose will be given.

  • Dexmedetomidine infusionDrug

    Also called Precedex Infusion

    Patients will receive an intravenous infusion of dexmedetomidine 0.7 - 1.5 mcg/kg/hour, titrated similarly to maintain a RASS score of -2 to 0. No bolus dose will be given.

Study groups in NCT07781462
Study groupRoleWhat they receive
Ketamine ArmActive comparatorPatients will receive an intravenous infusion of ketamine at a dose of 0.2 - 0.5 mg/kg/hour, titrated to achieve light sedation (RASS -2 to 0). No bolus dose will be given.
Receives: Drug: Low dose ketamine infusion
Dexmedetomidine ArmActive comparatorPatients will receive an intravenous infusion of dexmedetomidine 0.7 - 1.5 mcg/kg/hour, titrated similarly to maintain a RASS score of -2 to 0. No bolus dose will be given.
Receives: Drug: Dexmedetomidine infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution of delirium

    Resolution of delirium within 72 hours of initiating treatment, assessed twice daily using the Confusion Assessment Method for the ICU (CAM-ICU) tool, measured as the proportion of patients who transition from CAM-ICU positive to CAM-ICU negative status.

    Measured: 72 hours from initiating treatment

Secondary outcomes (6)
  1. Hemodynamic stability, measured by changes in mean arterial pressure (MAP)

    Incidence of significant hypotension (Mean Arterial Pressure < 60 mmHg or requiring initiation/increase of vasopressor support), or Incidence of significant hypertension (Systolic BP > 180 mmHg requiring new antihypertensive therapy).

    Measured: During active infusion (Baseline, and at 1, 2, 4, 8, 12, and 24 h); and for 6 hours post-infusion cessation.

  2. Hemodynamic stability, measured by changes in heart rate (HR)

    Incidence of significant bradycardia (Heart Rate < 40 bpm or requiring intervention [e.g., atropine, pacing]) or Incidence of tachycardia (Heart Rate > 120 bpm sustained for >10 minutes).

    Measured: During active infusion (Baseline, 1, 2, 4, 8, 12, and 24 h); and for 6 hours post-infusion cessation.

  3. Duration of Delirium

    Total number of days in the first 7 days with a positive CAM-ICU

    Measured: 7 days after admission

  4. ICU Length of Stay

    Number of days the patient stayed in the ICU (Days from ICU admission to ICU discharge)

    Measured: From ICU admission to discharge. Censored at Day 30.

  5. Hospital Length of Stay

    Total number of days the patient spent in the hospital

    Measured: From hospital admission to discharge. Censored at Day 30.

  6. In-Hospital Mortality

    All-cause mortality during hospitalization.

    Measured: up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled, parallel-group clinical trial. After the enrollment, patients will be randomized (allocation in a 1:1 ratio) to receive either low-dose ketamine infusion or dexmedetomidine infusion.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07781462
Sponsor's protocol ID
0109321
Status last verified
Nov 2025
First submitted
8 Aug 2026
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Low dose ketamine infusion and Dexmedetomidine infusion in people with Delirium in Intensive Care Unit and Acute Heart Failure (AHF), run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nada H Abd El-Rahim, PharmD (01008328380, gs-nada.hesham@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of delirium (time frame: 72 hours from initiating treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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