A Phase 4 interventional study of Low dose ketamine infusion and Dexmedetomidine infusion in Delirium in Intensive Care Unit and Acute Heart Failure (AHF), sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Alexandria University · Phase 4, Interventional, and Treatment
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.
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.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 150 is above the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Confirmed active ICU delirium at enrollment, as defined by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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
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.
Time frame: 72 hours from initiating treatment
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).
Time frame: 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)
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).
Time frame: During active infusion (Baseline, 1, 2, 4, 8, 12, and 24 h); and for 6 hours post-infusion cessation.
Duration of Delirium
Total number of days in the first 7 days with a positive CAM-ICU
Time frame: 7 days after admission
ICU Length of Stay
Number of days the patient stayed in the ICU (Days from ICU admission to ICU discharge)
Time frame: From ICU admission to discharge. Censored at Day 30.
Hospital Length of Stay
Total number of days the patient spent in the hospital
Time frame: From hospital admission to discharge. Censored at Day 30.
In-Hospital Mortality
All-cause mortality during hospitalization.
Time frame: up to 30 days
Plan to share: Undecided
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Studies of the drugs tested here: Ketamine · Dexmedetomidine