Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000700831
Ethics application status
Approved
Date submitted
25/10/2020
Date registered
8/06/2021
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Date results information initially provided
8/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acute effect of chlorpromazine on body temperature in intensive care unit patients
Scientific title
The acute effect of single dose of chlorpromazine treatment on body temperature alterations in intensive care unit patients
Secondary ID [1] 302573 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adverse drug reaction 319470 0
Condition category
Condition code
Anaesthesiology 317436 317436 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 318871 0
Not applicable
Comparator / control treatment
Patients with temperatures above 38 °C as comparator group.
Control group
Active

Outcomes
Primary outcome [1] 325473 0
Body temperature alterations will be evaluated by non-invasive measurements made from the tympanic membrane.
Timepoint [1] 325473 0
Body temperatures will be measured at 0th, 1st, 2nd, 4th, 6th, 8th, 10th, and 12th hours (endpoint) of the treatment
Primary outcome [2] 325474 0
Serum biomarkers related with systemic inflammation and pyrexia such as white blood cells (WBC), C-reactive protein (CRP), and procalcitonin (PCT) levels will be assessed.
Timepoint [2] 325474 0
Serum biomarkers will be evaluated with routine blood samples taken at any time within 24 hours prior to chlorpromazine treatment.
Secondary outcome [1] 389179 0
The safety of chlorpromazine will be evaluated by continuous monitoring and clinical examination.
Timepoint [1] 389179 0
The safety of chlorpromazine application will be evaluated for 12 hours after chlorpromazine treatment
Secondary outcome [2] 389180 0
28-day ICU mortality will be assessed by following patients in ICU.
Timepoint [2] 389180 0
ICU mortality will be assessed during intensive care stay for 28 days.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Chi-squared or Fisher’s exact tests, Shapiro-Wilk test, Independent-Samples t-test, Mann-Whitney U test, Repeated measures analysis of variance (rANOVA), Pearson’s correlation test, Receiver operating characteristic (ROC) analysis, Logistic regression analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
1/07/2019
Date of last data collection
Anticipated
Actual
29/07/2019
Sample size
Target
62
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 23075 0
Turkey
State/province [1] 23075 0
Konya

Funding & Sponsors
Funding source category [1] 307005 0
University
Name [1] 307005 0
Selcuk University
Country [1] 307005 0
Turkey
Primary sponsor type
University
Name
Selcuk University
Address
Selcuk University Medical Faculty, Alaaddin Keykubat Yerleskesi, Postal code: 42130, Selcuklu-Konya/TURKEY
Country
Turkey
Secondary sponsor category [1] 307573 0
None
Name [1] 307573 0
Address [1] 307573 0
Country [1] 307573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307137 0
Selcuk University Medical Faculty Ethics Committee
Ethics committee address [1] 307137 0
Selcuk University Medical Faculty, Alaaddin Keykubat Yerleskesi, Postal code: 42130, Selcuklu-Konya/TURKEY
Ethics committee country [1] 307137 0
Turkey
Date submitted for ethics approval [1] 307137 0
11/02/2016
Approval date [1] 307137 0
11/02/2016
Ethics approval number [1] 307137 0
2016/4

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106162 0
Dr Omur Ilban
Address 106162 0
Selcuk University Medical Faculty, Department of Anesthesiology and Raenimation, Alaaddin Keykubat Yerleskesi, Postal code: 42130, Selcuklu-Konya
Country 106162 0
Turkey
Phone 106162 0
+905052227998
Fax 106162 0
Email 106162 0
[email protected]
Contact person for public queries
Name 106163 0
Dr Mehmet Ali Bas
Address 106163 0
Selcuk University Medical Faculty, Department of Anesthesiology and Raenimation, Alaaddin Keykubat Yerleskesi, Postal code: 42130, Selcuklu-Konya
Country 106163 0
Turkey
Phone 106163 0
+905375425467
Fax 106163 0
Email 106163 0
[email protected]
Contact person for scientific queries
Name 106164 0
A/Prof Faruk Cicekci
Address 106164 0
Selcuk University Medical Faculty, Department of Anesthesiology and Raenimation, Alaaddin Keykubat Yerleskesi, Postal code: 42130, Selcuklu-Konya
Country 106164 0
Turkey
Phone 106164 0
+905057649235
Fax 106164 0
Email 106164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.