Hope-icu trial

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tarix	26.06.2016
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3.4.6 Safety

Extrapyramidal side effects.
Hypotension
Prolongation of QTc interval
Other side effects sufficient to stop treatment with trial drug
Serious adverse events including torsades de pointes and neuroleptic malignant syndrome.
Suspected unexpected serious adverse events.

3.5 Eligibility Criteria

3.5.1 Inclusion Criteria

Patients who require mechanical ventilation within 72 hours of admission to ICU regardless of whether they are screened to be positive for ICU delirium.

3.5.2 Exclusion Criteria

Subjects fulfilling any of the criteria below will be excluded from the trial:

Allergy to haloperidol
Patients with moderate/severe dementia as documented by medical history
Chronic antipsychotic use
Corrected QTc interval (QTc) > 500 ms
History of torsades de pointes
History of neuroleptic malignant syndrome
Family history of dystonic reactions to drugs
Age < 18 years
Pregnancy
Parkinson’s Disease
Structural brain damage
Moribund patients not expected to survive 48 hours
Patients predicted to stay less than 48 hours
Elective uncomplicated surgery
Study patients who are readmitted to ICU.

3.6 Screening of patients not suitable for trial

Limited anonymised routinely collected patient demographics of all patients admitted to intensive care who require mechanical ventilation within 72 hours of admission but who do not fulfil the eligibility criteria will be recorded on a Patient Screening Log.

3.7 Consent

The Chief Investigator is responsible for ensuring that informed consent for trial participation is given by each patient or a legal representative. An appropriately trained doctor or nurse may take consent. Appropriate signatures and dates must be obtained on the informed consent documentation prior to collection of trial data and administration of the trial drug. If no consent is given a patient cannot be randomised into the trial.

Consent will be sought from the patients themselves if this is possible, but it is recognised that in the majority of cases patients will be unable to give informed consent due to delirium itself or alterations in their level of consciousness caused by illness and therapeutic sedation. In this situation consent will be sought from a Personal Legal Representative or a Professional Legal Representative.

3.7.1 Patient consent

Whenever possible, informed consent will be obtained from the patient. The patient will be informed about the trial by the responsible clinician or a member of the research team and given a copy of the Patient Information Sheet (PIS). Informed patients will be given an adequate amount of time to consider their decision on trial entry. If the patient decides to enter the trial they will be asked to sign two copies of the Patient Consent Form, which will then be countersigned by the responsible clinician. The patient will retain one copy of the signed consent form. The second copy will be photocopied and the original placed in the patient’s medical records while the photocopy will be retained in the Trial Site File.

3.7.2 Personal Legal Representative Consent

If the patient is unable to give consent, informed consent will be sought from the patient’s ‘Personal Legal Representative’ (PerLR) who may be a relative, partner or close friend. The PerLR will be informed about the trial by the responsible clinician or a member of the research team and provided with a copy of the Covering Statement for Personal Legal Representative with attached PIS and asked to give an opinion as to whether the patient would object to taking part in such medical research. If the PerLR decides that the patient would have no objection to participating in the trial they will be asked to sign two copies of the PerLR Consent Form which will then be counter signed by the responsible clinician. The PerLR will retain one copy of the signed Consent Form. The second copy will be photocopied and the original placed in the patients’ medical records whilst the photocopy will be retained in the Trial Site File.

3.7.3 Professional Legal Representative Consent

If the patient is unable to give informed consent and no PerLR is available, a doctor who is not connected with the conduct of the trial may act as a Professional Legal Representative (ProfLR). The doctor will be informed about the trial by the responsible clinician or a member of the research team and given a copy of the PIS. If the doctor decides that the patient is suitable for entry into the trial they will be asked to sign two copies of the Professional Legal Representative Consent Form. The doctor will retain one copy of the signed Consent Form. The second copy will be photocopied and the original placed in the patient’s medical records; the photocopy will be retained in the Trial Site File.

3.7.4 Retrospective Patient Information

Patients for whom consent is given by a PerLR or ProfLR will be informed of their participation in the trial by the responsible clinician or a member of the research team once they regain capacity to understand the details of the trial. The responsible clinician will discuss the study with the patient and the patient will be given a copy of the PIS to keep. The patient will be asked for consent to participate in the trial and to sign the Consent to Continue Form.

3.7.5 Withdrawal of Consent

Patients may withdraw or be withdrawn (by PreLR or ProfLR) from the trial at any time without prejudice. Data recorded up to the point of withdrawal will be included in the trial analysis. If a patient or PerLR requests termination of infusion of the trial drug during the treatment period, the study drug will be stopped but the patient will continue to be followed-up as part of the trial. If a patient or a PerLR withdraws consent during trial treatment, the trial drug will be stopped but permission will be sought to access medical records for data related to the trial. If a patient or PerLR wishes to withdraw from the trial after completion of trial treatment, permission to access medical records for trial data will be sought.

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