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

NCT07781462 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 0109321
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Delirium in Intensive Care Unit; Acute Heart Failure (AHF)

Keywords

Ketamine; Dexmedetomedine; Delirium; Treatment; Acute Heart Failure; Intravenous Infusion; Low-dose Ketamine; Heart Failure

Outcome Measures

Primary Outcomes (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.

  72 hours from initiating treatment

Secondary Outcomes (6)

• Hemodynamic stability, measured by changes in mean arterial pressure (MAP)

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

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

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

• Duration of Delirium

  7 days after admission

• ICU Length of Stay

  From ICU admission to discharge. Censored at Day 30.

• Hospital Length of Stay

  From hospital admission to discharge. Censored at Day 30.

Study Arms (2)

Ketamine Arm

ACTIVE COMPARATOR

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.

Drug: Low dose ketamine infusion

Dexmedetomidine Arm

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine infusion

Interventions

Low dose ketamine infusion DRUG

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.

Ketamine Arm

Dexmedetomidine infusion DRUG

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.

Also known as: Precedex Infusion

Dexmedetomidine Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Main University Hospital (AMUH)

Alexandria, 21500, Egypt

Location

MeSH Terms

Conditions

Delirium; Heart Failure

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 24, 2026

Record last verified: 2025-11

Locations

EG (1)