None listed
Conditions
Brief summary
Aim: Hypothermia is a rare complication of antipsychotic drugs but serious outcomes including death may result. In this prospective observational study, we will analyze patients’ body temperatures for 12 hours after 25 mg IV chlorpromazine administered for agitation and the relationship of inflammatory indicators with adverse drug reaction (ADR) development. Methods: Patients will divide according to baseline body temperatures into Group 1 with temperatures less than or equal to 38°C and Group 2 with temperatures >38°C. Also, recurrent measurements for 12 hours will make at specific intervals following 25 mg intravenous chlorpromazine. Serum biomarkers related with systemic inflammation and pyrexia such as white blood cells (WBC), C-reactive protein (CRP), and procalcitonin (PCT) levels will measure. Length of ICU stay and 28-day mortality rate will record.
Interventions
Whether the participants who needed sedative therapy due to agitation would take chlorpromazine or not was independent of their participation in this study. Patients will be divided into two groups according to baseline body temperatures, 30 patients (16 males, 14 females) with temperatures less than or equal to 38 °C as Group 1, and 33 patients (18 males, 15 females) with temperatures above 38 °C as Group 2. For treating agitation, 25 mg single dose chlorpromazine will be applied by intravenous
Whether the participants who needed sedative therapy due to agitation would take chlorpromazine or not was independent of their participation in this study. Patients will be divided into two groups according to baseline body temperatures, 30 patients (16 males, 14 females) with temperatures less than or equal to 38 °C as Group 1, and 33 patients (18 males, 15 females) with temperatures above 38 °C as Group 2. For treating agitation, 25 mg single dose chlorpromazine will be applied by intravenous (IV) slow infusion within 30 minutes to the patients enrolled in the study. Body temperatures for both groups will be measured by digital thermometer at 0th, 1st, 2nd, 4th, 6th, 8th, 10th, and 12th hours of the treatment.
Sponsors
Selcuk University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
After obtaining participants' informed consent, 63 patients, who were aged 18-85 years and stayed in ICU for at least 24 hours after admission will enroll in the study.
Exclusion criteria
Schizophrenia, hyperthermia syndromes (e.g., malignant hyperthermia, neuroleptic malignant syndrome), endocrinal states which may cause hyperthermia, shock states (with lactic acid levels > 4 mmol), diagnosed hepatitis (with alanine aminotransferase levels more than twice the upper limit), chronic hepatic insufficiency, pregnancy, breastfeeding, use of medications (such as antibiotics, steroids, non-steroid anti inflammatory drugs, antipyretics, sedative-hypnotics, and anticonvulsants), and history of blood product transfusion or surgery within 24 hours will exclude from the study.
Outcome results
None listed