Dexmedetomidine in delirium at the end of life
Dexmedetomidine for delirium at the end of life: an open-label single arm study with dose escalation for terminal delirium in patients admitted to an inpatient palliative care unit
Illawarra Shoalhaven Local Health District
22 participants
Nov 7, 2018
Interventional
Conditions
Summary
Patients near the end of life may suffer from delirium that can be difficult to control; with up to 88% of inpatients in palliative care units suffering from a terminal delirium. The current practice within the Illawarra Shoalhaven Local Health District (ISLHD) for patients suffering from a terminal delirium is to first attempt to reverse or treat any causes found, such as urinary retention and pain. If delirium proves to be irreversible, patients are typically given a continuous subcutaneous infusion (CSCI) of a benzodiazepine (midazolam), often in combination with an antipsychotic medication (haloperidol), with the aim of providing sedation to alleviate distress. If these medications are unable to alleviate a terminal delirium, the medication can be altered to include an infusion of levomepromazine, an antipsychotic, or phenobarbital, a barbiturate. With the above regimen, the majority of patients with terminal agitation will find symptom relief but will often become unable to eat, drink or interact with their loved ones. Patients who currently suffer with terminal delirium admitted to the Port Kembla palliative care unit are provided with symptom relief via CSCI of midazolam infusion, with escalation to other agents per the European Association of Palliative Care (EAPC) framework for sedation in palliative medicine. Prognosis for patients with a terminal delirium is measured in a number of days to a week, and rarely extends beyond that timeframe. Patients suffering from worsening delirium and agitation, however, are often still verbal but the intractable nature of their suffering means that deeper sedation is the only current way available to provide them peace and dignity. Access to an option that may provide some resolution of the delirium without as deep a sedation so that the patient could interact with family and friends would be of benefit in these circumstances. Dexmedetomidine is a novel agent for managing intractable symptoms in palliative medicine towards the end of life. It has the attribute of decreasing the frequency and severity of delirium, as well as analgesic benefits to assist in the management of pain and delirium. Of particular interest to patients towards the end of life who would like to continue to communicate with loved ones and be involved in decision-making is the potential ability to be woken when dexmedetomidine is utilised for sedation instead of midazolam, levomepromazine or phenobarbital. These features have been well studied in anaesthesia and in the ICU, with only case reports in palliative medicine. Given the gap in knowledge we propose a Phase 2 trial for the utilisation of dexmedetomidine via CSCI in patients with a terminal delirium in an inpatient palliative care unit. The goal of this study is to answer the following question: does dexmedetomidine provide effective relief from confusion and delirium at the end of life, with rousability, as assessed on standardised delirium and rousability scores
Eligibility
Inclusion Criteria4
- Admitted to the Port Kembla Palliative Care Unit at Illawarra Shoalhaven Local Health District
- English Speaking
- Develop a terminal delirium during admission
- End of life
Exclusion Criteria5
- Non English speaking
- Severe left ventricular dysfunction of <20% EF
- Severe renal failure of eGFR of 30 or less
- Severe hepatic failure with MELD score of 30 or greater
- Bradycardia with restring heart rate of <65 BPM on screening
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Subcutaneous Dexmedetomidine infusion at End of Life For patients approaching the end of life with delirium, dexmedetomidine will be administered by a continuous subcutaneous infusion (CSCI). Infusion will be given as a 2-tier protocol. Effect of dexmedetomidine will be assessed by delirium scoring (diagnosed with MDAS tool by treating clinician and assessed be MDAS daily, in addition to NuDESC ongoing in domains of inappropriate communication, illusions and hallucination, inappropriate behaviours). Rousability will be assessed by RASS scoring. Tier 1 0.3microg/kg (to nearest 10kg bodyweight, rounded down) for 24 hours via CSCI. If effective at controlling delirium (MDAS <13, NuDESC 2 or less in above domains, minimum rescue medication) with reasonable sedative scores (RASS score between -1 and -3), will maintain. If not, escalate to Tier 2. Tier 2 0.6microg/kg (to nearest 10kg bodyweight, rounded down) for 24 hours via CSCI. If effective at controlling delirium (MDAS <13, NuDESC 2 or less in above domains, minimum rescue medication) with reasonable sedative scores (RASS score between -1 and -3), maintain dosing. If ineffective. withdraw dexmedetomidine and institute prior standard care for terminal delirium. Doses will be calibrated to nearest 10microg/24 hours. For both tiers: 1. Access to rescue medication (as required midazolam subcutaneous injection and haloperidol subcutaneous injection) will be ensured 2. Reversible causes of delirium will be assessed and treated in line with goals of care 3. Bowel and bladder function will be assessed and normalised as possible 4. Dexamedetomidine will be administered via continuous subcutaneous infusion pump (syringe driver), prescribed by the treating physician and administered by the ward nurses. 5. Maximum duration of infusion will be until death (expected maximum 10 days) 6. Crossover to standard care if consent withdrawn or at clinical concerns, side effects mandate, ineffective treatment.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12618000658213