NCT05029050

Dexmedetomidine or Clonidine Infusion for Prevention of Delirium After Open Heart Surgery

Alpha 2 Adrenergic Receptor Agonists for the Prevention of Delirium and Cognitive Decline After Open Heart Surgery (ALPHA2PREVENT): Randomised Controlled Trial.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

A parallel-group treatment, five-centre, participant and investigator masked, three-arm study to assess the safety and effectiveness of dexmedetomidine or clonidine infusion compared to placebo for the prevention of delirium and cognitive decline in male and female participants aged 70+ scheduled for open heart surgery.

Detailed description

Delirium is a major public health concern without therapeutic options. It is an acute disturbance of attention and cognition, precipitated by an acute somatic condition. Delirious patients are often subject to off-label treatment with psychotropic drugs that have dubious effects. The intravenous alpha-2-adrenergic receptor agonist dexmedetomidine, attenuating sympathetic nervous system activity, shows promise as treatment for delirium, but its use is limited to intensive care units (ICU). Its long-term cognitive effects are unknown. Clonidine is a pharmacodynamically similar drug that can be given orally and has been used for decades as an antihypertensive agent, but is else sparsely studied. ALPHA2PREVENT will be a three-armed randomised controlled trial to study 1) whether repurposing of clonidine can represent a novel treatment option for delirium, and 2) the possible effects of both dexmedetomidine and clonidine on long-term cognitive trajectories, motor activity patterns, patient rated outcome measures and biomarkers of neuronal injury.

Conditions

• Delirium
• Cognitive Decline
• Frailty

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Continous intravenous infusion
DRUG	Clonidine	Continous intravenous infusion
DRUG	Natriumchlorid	Continous intravenous infusion NaCl

Timeline

• Start date: 2022-01-17
• Primary completion: 2024-07-01
• Completion: 2025-01-01
• First posted: 2021-08-31
• Last updated: 2024-04-30

Locations

5 sites across 1 country: Norway