The effects of the medicine Ketanserin on Peripheral Temperature and Lactate

Phase 1

Conditions: Critical illnessDelta temperature greater than 6.0 °C
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Registration Number: EUCTR2017-003362-27-NL

Lead Sponsor: OLVG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

-DeltaTemperature greater than 6.0 °C.
-Age 18 years or older
-Admitted to the ICU for any reason
-Written informed consent from the patient or legal representative

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

-Pregnancy
-No possibility to obtain informed consent
-QTc above 550 msec,
-Arrhythmias, including bradycardia defined as a heart rate below 50/min; 2nd and 3rd degree AV block; ventricular tachycardia
-Blood Potassium level < 3.5 mmol/l
-Blood Magnesium level <0.5 mmol/l
-Allergy for ketanserin
-DeltaTemperature less than 6°C.
-Patients undergoing therapeutic hypothermia
- Patients admitted after cardiac arrest
- Patients admitted after cardiac surgery

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Change in DeltaTemperature (measured per hour);Timepoint(s) of evaluation of this end point: Temperature measurements<br>Time=0 hour (start infusion IMP or placebo) <br>T= 1 hour (after start infusion), T= 2 hour, T= 3 hour, T=4 hour, T= 5 hour, T= 6 hour, T= 7 hour, T= 8 hour (stop infusion IMP or placebo);Main Objective: To determine the effects of a continuous ketanserin infusion on peripheral temperature and lactate clearance in critically ill patients with either a high lactate or a high deltaTemperature.;Secondary Objective: Change in lactate (measured per 2 hours)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Change in lactate (measured per 2 hour)<br><br>-To determine ketanserin serum levels in retrospect. <br>;Timepoint(s) of evaluation of this end point: - To calculate lactate clearance every two hours a 2 ml arterial blood sample for lactate measurement will be collected and sent for immediate analysis : T=0 hour (start infusion IMP or placebo) , T= 2 hour, T=4 hour, T= 6 hour, T= 8 hour (stop infusion IMP or placebo) <br><br>- At T=4 hr and T=8 hr a 6 ml blood sample will be drawn to determine ketanserin serum levels in retrospect.