Health TrialsbyHealthPanel

Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)

ConditionDelirium
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorMassachusetts General Hospital

About this trial

This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 60 years or older

Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass

Planned postoperative admission to the intensive care unit (ICU)

Disqualifiers

Allergy or hypersensitivity to dexmedetomidine or the placebo study medication

Preexisting diagnosis of Alzheimer's Disease or Related Dementia, severe cognitive impairment or delirium at baseline

Severe liver failure (Child-Pugh score > 5)

Severe deficit(s) due to structural or anoxic brain damage

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous Dexmedetomidine

    Drug

    Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)

  • Sublingual Dexmedetomidine

    Drug

    Sublingual dexmedetomidine (120 μg)

  • Intravenous Placebo

    Drug

    Intravenous placebo of 0.9% saline administered over 40 minutes

  • Sublingual Placebo

    Drug

    Inert sublingual film

Treatment groups

1,800 Participants
are divided into 3 treatment groups
Group A: Intravenous DexmedetomidineExperimental treatment 2 interventions
Group B: Sublingual DexmedetomidineExperimental treatment 2 interventions
Group C: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Delirium

The primary outcome will be delirium occurring on postoperative day one. Delirium will be assessed using the Confusion Assessment Method (CAM) twice daily. Delirium will be defined as present if either the morning or afternoon assessment are positive for delirium.

Time frame
Postoperative day 1

Secondary outcomes

1

Delirium

Postoperative delirium will also be assessed as a secondary outcome assessed within the first three days after surgery, and separately within the first seven days following surgery. Delirium will be assessed using the CAM in the same fashion as the primary outcome. In the event the patient is reintubated the CAM-ICU may also be used to assess for postoperative delirium as a secondary outcome.

Time frame
Postoperative Day 1 to Day 7
2

Delirium Severity

Delirium severity will be assessed using the CAM-Severity (CAM-S) within the first three days following surgery, and separately within the first seven days following surgery. The CAM-S ranges from 0 (no delirium features) to 19, with higher scores indicating worsening delirium severity.

Time frame
Postoperative day 1 to day 7
3

Telephonic Montreal Cognitive Assessment

Global cognitive function will be assessed with the T-MoCA in-hospital and at three time points after hospital discharge. Different versions of the T-MOCA will be administered at each time point to minimize learning effects. The T-MoCA ranges from 0 (worst) to 22 (best) points, does not require visual cues or writing, and importantly, can be administered over the phone.

Time frame
30, 180 and 365 days
4

Global Health

Global health will be assessed at 30, 180 and 365 days using the Patient Reported Outcome Measurement Information System (PROMIS) 29 Profile version 2.1. This assessment results in several subscale scores, each reported as a t-score.

Time frame
30, 180 and 365 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now