Table 2 List of endpoints and measurements for efficacy assessment
Endpoint | Measurements for efficacy assessment |
|---|---|
Primary | |
Delirium trajectory | MDAS |
Secondary (also with subanalyses for subsyndromal delirium and hypoactive/hyperactive/mixed delirium) | |
Time-to-first delirium resolution | DSM-5 |
Incidence of “full-scale” delirium | DSM-5 |
Severity of delirium | MDAS, OSLA |
Delirium subtype | MDAS, OSLA, DelApp |
Use of “rescue medication”/additional drugs (as other sedatives, analgetics and antipsychotics) | Registration of use of all medication |
Length of hospital stay | Registrations |
Patient distress | Checklist of Nonverbal Pain Indicators |
Cognitive function in follow-up after 4 months | MMSE-NR, Clock drawing test, Ten-words memory test, Trial making test A and B, IQCODE, CDR |
Independence in follow-up after 4 months | Barthel ADL, NEADL |
Pharmacokinetic response to clonidine | Serum drug concentrations |
Pharmacodynamic response to clonidine | BP, HR, ECG, RASS, OSLA, symptoms of bradycardia, orthostatic hypotension or other side-effects |
Biomarkers | Blood samples |
Institutionalisation | Registrations |
Survival | Registrations |
Safety | |
Side effects of clonidine/in-hospital complications | BP, HR, ECG, sedation (RASS, OSLA), and any symptoms of bradycardia, orthostatic hypotension or other side-effects |