Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle

Browse trials for

• Delirium 933
• Critical Illness 1,780

Keywords

• delirium
• dexmedetomidine
• sleep
• intensive care unit
• polysomnography

Delirium

933 studies on the registry are indexed under Delirium; 190 are open to participants now.

This study's planned enrollment of 50 is below the median of 112 across 550 interventional studies indexed under Delirium.

Lead sponsor

University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Study arms

• Experimental
  Intervention

  Dexmedetomidine will be prepared at a concentration of 4 mcg/ml by diluting 200 mcg/2 ml vials with 48 mL of 0.9% normal saline to a total volume of 50 ml. A maintenance infusion of 0.2-1.2 mcg/kg/hr will be initiated to sustain the sedative effect and promote sleep throughout the trial period. ICU nurses are experienced in titrating dexmedetomidine for both patients on high flow oxygen (optiflow) and intubated patients with delirium as part of routine care.

  Drug: Dexmedetomidine

• Placebo comparator
  Control

  Patients randomized to the control group will receive a placebo daily for 2 consecutive nights.

  Other: Control (placebo) group

Interventions

• DrugDexmedetomidine

  Dexmedetomidine will be prepared at a concentration of 4 mcg/ml by diluting 200 mcg/2 ml vials with 48 mL of 0.9% normal saline to a total volume of 50 ml. A maintenance infusion of 0.2-1.2 mcg/kg/hr will be initiated to sustain the sedative effect and promote sleep throughout the trial period. ICU nurses are experienced in titrating dexmedetomidine for both patients on high flow oxygen (Optiflow) and intubated patients with delirium as part of routine care. The ICU bedside nurse will be responsible for using the lowest effective dose to achieve a Richmond Agitation Sedation Scale (RASS) of -2, up to a maximum of 1.2 mcg/kg/hr, while monitoring for adverse events such as bradycardia and hypotension.

• OtherControl (placebo) group

  The control group will receive an infusion of 0.9% saline at 5-45 ml/hr titrated to the lowest effective dose to achieve a RASS of -2 for two nights following randomization.

Primary outcomes

1. Recruitment rate

   The number of participants enrolled per month will be reported with 95% confidence intervals. A recruitment rate of at least one participant per month per participating site will be considered supportive of progression to a larger trial.

   Time frame: 2 years

Secondary outcomes

1. Protocol Adherence

   Adherence to treatment duration protocol: The investigators will consider the main trial to be feasible if intervention is delivered 90% of scheduled duration (proportion of total hours study drug received during intervention period (20:00 - 06:00). Further, tolerance of Prodigy Sleep Machine will be evaluated for a similar proportion of time successfully worn (recordings that are of sufficient quality to permit analyses between 20:00 - 06:00). The investigators will report proportion of adherence with 95% confidence intervals.

   Time frame: 2 years

2. Sleep Quality Assessment

   We will monitor overnight sleep using the NOXA1s Sleep System. A trained assessor will attach the device at 17:00, remove the device at 08:00 the following morning and reattach at 17:00 later the same day. The patients will undergo the sleep study for one night prior to randomization, if the quality of data is deemed acceptable then they will be randomized to one of the two experimental groups (dexmedetomidine or placebo) and undergo the sleep study for two additional nights for a maximum of three consecutive nights. The sleep assessment will be performed with the associated Noxturnal Sleep Study software.

   Time frame: 2 years

Individual participant data

Plan to share: Yes — al investigator and Steering Committee approval, ethics approval or exemption where applicable, and a signed institutional data-sharing agreement prohibiting re-identification and unauthorized onward sharing. Data will be provided securely, consistent with participant consent, ethics approvals and institutional requirements.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: De-identified IPD and supporting information will be available beginning 12 months after publication of the primary DELDEX pilot trial results and for five years thereafter.

Access criteria: Qualified researchers may request de-identified IPD underlying the published results, a data dictionary, the study protocol and SAP for verification, secondary analyses or IPD meta-analyses. Requests must be submitted to the principal investigator using the contact details in the trial record and include the research question, requested data, analysis plan and secure data-handling arrangements. Access requires approval by the principal investigator and Steering Committee, research ethics approval or exemption where applicable, and a signed institutional data-sharing agreement prohibiting re-identification and unauthorized onward sharing. Approved materials will be provided through secure institutional transfer or access, consistent with participant consent, ethics approvals and institutional requirements.