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NCT07781462Not yet recruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 24 Aug 2026

Brief summary (registry, in English)

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. 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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
150 (estimated)
First submitted
8 Aug 2026
Start date
Sept 2026
Primary completion date
Sept 2027
Lead sponsor
Alexandria University
NCT number
NCT07781462

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 150
  • From Sept 2026 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Primary neurological events (e.g., stroke, seizure, traumatic brain injury) as cause of altered mental status.
  • Known hypersensitivity or contraindication to ketamine or dexmedetomidine.
  • History of psychosis, schizophrenia, or substance use disorder.

Lab values

  • Severe hepatic dysfunction (e.g., Child-Pugh Class C) or renal impairment (eGFR \< 30 mL/min/1.73m²).

Other

  • Current or recent (within 48 hours) use of antipsychotics, benzodiazepines, or other sedatives.
  • Pregnant or lactating women.
  • Patients requiring deep sedation or neuromuscular blockade for clinical reasons.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Alexandria Main University Hospital (AMUH)
Coordinator of this site? Confirm its status
AlexandriaEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.