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Hope-icu trial

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3.9.7 Treatment compliance

Site personnel with relevant training and experience at the hospital will administer the treatment to patients. Trial drugs given will be recorded in the Case Report Forms to monitor treatment compliance.

3.9.8 Drug accountability

Preparation of all drug doses will be recorded on the Nursing Staff Drug Accountability Form and on the patient’s prescription chart.
3.9.10 Blood sampling (mechanisms)

10 mls of blood will be taken for plasma beta amyloid measurement. All study patients on admission have an arterial line as part of routine ICU monitoring and the blood sample will be withdrawn from this arterial line.

Plasma from each sample will be stored at –20oC at the local site until analysis. Blood will be stored beyond study completion for additional biomarker studies pending additional ethical approval.

3.10 Clinical management of Patients in the Trial

Patients involved in the HOPE trial will be managed according to best practice established on the ICU. Particular care regarding ECG monitoring and extra-pyramidal symptoms is required.
3.10.1 Rescue protocol for delirium

If patients who develop acute agitation while on the study drug the following steps will be taken until the patient’s agitation has settled:

  1. Manage reversible cause such as pain or a blocked urinary catheter.

  2. If they are on an opioid infusion give a bolus dose of 1-2 mls and increase the infusion.

  3. If the patient is on a sedative infusion of propofol, give a bolus dose of 20 mgs, repeat as necessary and increase the infusion until the patient’s agitation settles.

  4. If the patient’s agitation does not settle with these measures give the patient up to 10mgs of haloperidol in divided doses intravenously and document in CRF.

After the study period the attending clinician will decide how to treat a patient’s delirium. The number and dose of any antipsychotics given to any study patient following the end of the study period and before discharge will be recorded in the CRF.

3.10.2 Sedation management

The daily sedation goal for all patients will be RASS –1 unless a patient’s clinical condition requires a deeper level of sedation e.g. patient with severe ARDS or the patient is weaning from ventilation.

The drugs used before patients are consented for the study will be the decision of the responsible intensivist. Once consented for the study patients will be maintained using fentanyl and propofol infusions while requiring ventilation. The infusion rate will be titrated according to RASS assessment and the nurse’s assessment of when a patient is experiencing pain. Daily sedation breaks will be done in all patients according to normal practice. Daily spontaneous breathing trials will be done at the discretion of the consultant Intensivist responsible for clinical management according to routine unit practice.

3.10.3 Extrapyramidal symptoms

Patients will be monitored for extrapyramidal symptoms using a modified Simpson-Angus scale. If a patient develops extrapyramidal symptoms the study drug dose will be halved. If the symptoms continue despite dose reduction the study drug will be stopped.

If the intensivist responsible for the clinical supervision of the patient considers the EPS requires symptomatic treatment with intravenous procyclidine the study drug will be stopped.

3.10.4 Prolonged QTc

Study patients will have an ECG recorded before commencing the study and then every 24 hours while on the study drug. If the QTc is longer than 500 msecs any study drug administration will be stopped until any hypokalaemia or hypomagnesemia is corrected. Once the QTc is less than 500 msecs the study drug will then be restarted at half the dose. If the patient was already on half the dose – 1.25 mgs haloperidol or 0.25 mls 0.9% saline – due to other reasons (oversedation or EPS) the study drug will be stopped.

If the potassium and magnesium is normal and the QTc is over 500 msecs the study drug will be stopped.

All the study patients will have routine continuous ECG monitoring display. This will started before the first dose of study drug is administered and continued uninterrupted throughout the study period. The screen is on clear display at the patient’s bedside and viewed from the nurses station on a central screen. All ICU ventilated patients have a dedicated ICU nurse.

3.10.5 Blinding and procedures for unblinding trial patients

As a placebo controlled double blind trial, patients, clinicians caring for the patient and investigators will be blinded to the patient’s allocation. A qualified nurse will bring the trial drug to the patient’s bedside already prepared in a syringe and labelled only with patient name and number.

Emergency unblinding may be requested on the grounds of safety by any Intensive care consultant. Emergency unblinding will be performed by telephone contact with the recovery area. This option may be used ONLY if the patient’s future treatment requires knowledge of the treatment assignment. If the responsible Intensive care consultant decides that there is justification to unblind a patient, they should make every effort to contact the Chief Investigator (Dr Valerie Page) or a site co-investigator to discuss the necessity of unblinding.

3.11 Post treatment follow-up

Any patient who remains in the Critical Care unit for more than 14 days following randomisation (end of study period for primary outcome) will continue to be monitored on a daily basis until discharged to a ward. The date and place of discharge will be obtained from the hospital records.

All patients discharged from the hospital will be followed-up six months after randomisation by phone using a telephone cognitive examination, the modified telephone interview of cognitive status (TICS-M), and EQ-5D questionnaire40. The telephone EQ-5D questionnaire will collect data on disability and health-related quality of life. If the patient cannot be contacted on the phone numbers collected at the time of hospital admission one set of questionnaires with accompanying letter will be sent out to the patients last known address.

Where feasible there will be a surrogate assessment of any perceived cognitive decline by a carer or relative using a telephone version of the Informant Questionnaire on Cognitive Decline in the Elderly.

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