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The effect of Haloperidol on the survival of patients with severe infection

Effects of Haloperidol on mortality in septic shock: a randomized clinical trial - HALO-Shock Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3s3dkp3
Enrollment
107
Registered
2026-03-10
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Shock Septic Mortality

Interventions

This is a double-blind, randomized clinical trial. Eligible patients will be divided into two groups through randomization in blocks of 6 patients. Randomization will be performed by a researcher who
randomizer&quot
mobile application. The intervention group (54 participants) will receive 5 mg of intravenous Haloperidol every 12 hours for 3 days within 24 hours of hospital admission. The placebo group (54 partici

Sponsors

Universidade Estadual Paulista
Lead Sponsor
Universidade Estadual Paulista
Collaborator

Eligibility

Age
19 Years to No maximum

Inclusion criteria

Inclusion criteria: The inclusion criteria will be individuals over 18 years of age, of both sexes, admitted with a diagnosis of septic shock and on mechanical ventilation (MV) to the Intensive Care Unit of the Hospital das Clínicas of the Faculty of Medicine of Botucatu (HC/FMB) between March 2026 and February 2028

Exclusion criteria

Exclusion criteria: Pregnant women, patients with brain death or in palliative care, those with other types of shock (cardiogenic, hemorrhagic), those with a prolonged QTc interval on the electrocardiogram (greater than or equal to 450 ms for men and greater than or equal to 470 ms for women), as well as those whose legal representative/family member does not consent to participation by signing the Informed Consent Form (ICF), will be excluded

Design outcomes

Primary

MeasureTime frame
To assess the occurrence of hospital mortality, verified through the registration of death in the institutional electronic medical record during the period of hospital stay, with the outcome being considered when the participant's death is observed during hospitalization, expressed as an absolute number and percentage of deaths in each study group

Secondary

MeasureTime frame
To evaluate the duration of vasoactive drug use during hospital stay, verified through prescription and progress notes in the institutional electronic medical record, analyzing the total time of use of these medications during hospitalization, expressed in number of hours or days of use in each study group

Countries

BR

Contacts

Public ContactLetycia Cunha

Universidade Estadual Paulista

letycia.cunha@unesp.br62984154872

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026