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Prevention of Delirium in Intensive Care using low dose risperidone prophylaxis: arandomised placebo controlled trial

PREvention of DELirium in Intensive Care using low dose risperidone prophylaxis: a randomised placebo controlled trial (PREDELIC trial) - PREDELIC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/015955
Enrollment
90
Registered
2018-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Adult patients admitted to the medical intensive care unit

Interventions

Intervention1: Low dose risperidone: Syrup Risperidone 1mg per orally twice daily for the duration of ICU stay Control Intervention1: Placebo: Identical syrup 1ml twice daily per orally for the durati

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted to the medical intensive care unit

Exclusion criteria

Exclusion criteria: No informed consent obtained Neurological disease(including post-cardiac arrest patients) Come due to drug overdose Alcohol withdrawal Antipsychotic therapy in the last 30 days Pregnancy or breast feeding Documented delirium prior to IUD admission Difficulty in CAM ICU assessment (serious auditory or visual disorders, mentally disabled) Expected ICU stay less than 1day Moribund and not expected to survive 2 days Known risperidone allergy Severe hemodynamic instability requiring vasopressors more the 20mcg/min Renal failure eGFR less than 30ml/min Liver failure child Pugh B/C

Design outcomes

Primary

MeasureTime frame
Incidence of delirium in the study patients as assessed by the CAM-ICU scoreTimepoint: During ICU stay

Secondary

MeasureTime frame
Duration of ICU stay Duration of hospital stay Mortality at 28 daysTimepoint: Follow up till 28 days

Countries

India

Contacts

Public ContactAmita Jacob

CMC, vellore

ocabraham@cmcvellore.ac.in09003540268

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026