Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607663506431 Date of Registration: 23/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Haloperidol versus lurasidone for treatment of ICU delirium in critically ill adults: a randomized controlled trial
Official scientific title Efficacy and safety of haloperidol versus lurasidone in the treatment of ICU delirium in critically ill adult patients: a prospective randomized double-blind controlled clinical trial
Brief summary describing the background and objectives of the trial Delirium is a frequent neuropsychiatric complication among critically ill patients admitted to the intensive care unit (ICU) and is associated with prolonged ICU stay, increased morbidity, and poor clinical outcomes. Haloperidol has traditionally been used for management of ICU delirium, but concerns remain regarding its efficacy and adverse effects. Lurasidone is an atypical antipsychotic with a potentially favorable efficacy and safety profile, but evidence for its use in ICU delirium remains limited. This study aims to compare the efficacy and safety of haloperidol versus lurasidone in the treatment of ICU delirium in critically ill adult patients. This is a prospective randomized controlled clinical trial conducted in the surgical ICU of Mansoura University Hospital, Egypt. Eligible adult ICU patients diagnosed with delirium will be randomly allocated to receive either haloperidol or lurasidone according to the study protocol. The primary and secondary outcomes will assess delirium improvement and safety outcomes during the study period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HAL-LUR ICU
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2025
Actual trial start date 05/07/2025
Anticipated date of last follow up 30/06/2026
Actual Last follow-up date 30/06/2026
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 64
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lurasidone Lurasidone 40 mg orally or via nasogastric tube once daily with food; titrated up to 80 mg daily as tolerated. Until resolution of delirium symptoms or maximum 14 days. Adult ICU patients with delirium received lurasidone for treatment of ICU delirium according to study protocol. Tablets could be crushed and administered via nasogastric tube if needed. 32
Control Group Haloperidol Haloperidol 0.5–2 mg IV every 6 hours, titrated according to agitation level, maximum 10 mg/day. If severe agitation persisted, continuous IV infusion 0.5–3 mg/h under ECG monitoring. Until resolution of delirium symptoms or maximum 14 days. Adult ICU patients with delirium received haloperidol for treatment of ICU delirium according to study protocol. 32 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients were eligible for inclusion if they met all the following criteria: 1.⁠ ⁠Age between 18 and 80 years. 2.⁠ ⁠Admitted to the ICU for any medical or surgical cause. 3.⁠ ⁠Diagnosed with delirium or psychosis according to DSM-5 criteria, confirmed by a positive CAM-ICU assessment . 4.⁠ ⁠Expected ICU stay ≥ 72 hours. 5.⁠ ⁠Informed consent obtained from the patient or legally authorized representative. Patients were excluded if any of the following applied: 1.⁠ ⁠Known hypersensitivity to haloperidol or lurasidone. 2.⁠ ⁠Preexisting major neurological or psychiatric disorders (e.g., Parkinson’s disease, schizophrenia). 3.⁠ ⁠Severe hepatic impairment (Child–Pugh class C) or renal failure requiring dialysis. 4.⁠ ⁠Baseline QTc>470 ms or concurrent use of QT-prolonging medications. 5.⁠ ⁠Pregnancy or lactation. 6.⁠ ⁠Coma, deep sedation, or inability to assess delirium clinicallyation of Helsinki. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2025 Medical research ethical committee institutional review board faculty of medicine Mansoura University
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine Mansoura University elgomhoria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Resolution of ICU delirium during the treatment period, assessed by a validated delirium assessment tool and comparison of response between haloperidol and lurasidone groups. Daily from baseline until delirium resolution or up to 14 days after treatment initiation.
Secondary Outcome Time to resolution of delirium symptoms in each treatment group. Measured daily from enrollment until delirium resolution or up to 14 days.
Secondary Outcome Length of ICU stay. From ICU admission until ICU discharge.
Secondary Outcome All-cause ICU mortality during the study period. Assessed during ICU stay up to 14 days or until ICU discharge/death.
Secondary Outcome Incidence of adverse drug effects, including extrapyramidal symptoms, excessive sedation, QTc prolongation, arrhythmias, and hemodynamic instability. Monitored daily during treatment and until completion of the 14-day follow-up period.
Secondary Outcome Need for rescue sedation or additional antipsychotic medication during ICU stay. Assessed throughout the treatment period up to 14 days.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital El Gomhoria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed helal Mansoura University hospital elgomhoria street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University El Gomhoria street Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Helal ahmedhelal350@gmail.com +201097931465 Elmahkma street
City Postal code Country Position/Affiliation
Dyarb Negm 44788 Egypt Resident doctor anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries Alaaedin Eldeeb ahmedhelal350@gmail.com +201097931465 Elgomhoria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Mahmoud abdelfattah Attia ahmedhelal350@gmail.com +201097931465 Elgomhoria
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor Anethesia and intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in this study will be available from the principal investigator upon reasonable request after publication, subject to institutional approval and ethical requirements Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol De-identified participant data will be available beginning 6 months after publication of the primary study results and for up to 5 years thereafter. Access to de-identified participant data will be granted to qualified researchers with a methodologically sound proposal. Requests will be reviewed by the principal investigator and the institution. A data access agreement and ethics approval may be required before access is granted.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 16/07/2026 Updated the applicable age groups to include participants aged 80 years Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/07/2026 Removed the word "group" as requested by the reviewer. Control Group, Haloperidol, Haloperidol 0.5–2 mg IV every 6 hours, titrated according to agitation level, maximum 10 mg/day. If severe agitation persisted, continuous IV infusion 0.5–3 mg/h under ECG monitoring., Until resolution of delirium symptoms or maximum 14 days., Adult ICU patients with delirium received haloperidol for treatment of ICU delirium according to study protocol., 32, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 16/07/2026 Corrected funding source details as requested by the reviewer. Self funded, Mansoura University hospital elgomhoria street, Mansoura , 35516, Egypt, Self Funded, Ahmed helal, Mansoura University hospital elgomhoria street, Mansoura , 35516, Egypt, Self Funded,