The effects of the medicine Ketanserin on Peripheral Temperature and Lactate

Ketanserin effects on Peripheral Temperature and Lactate - KoPTaL

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003362-27-NL

Enrollment

120

Registered

2017-10-24

Start date

2018-03-02

Completion date

Unknown

Last updated

2018-03-12

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

Conditions

Critical illness Delta temperature greater than 6.0 °C

Interventions

Trade Name: Ketanserin Product Name: Ketanserin Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Change in DeltaTemperature (measured per hour);Timepoint(s) of evaluation of this end point: Temperature measurements Time=0 hour (start infusion IMP or placebo) 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)	—

Measure

Time frame

Primary end point(s): Change in DeltaTemperature (measured per hour);Timepoint(s) of evaluation of this end point: Temperature measurements Time=0 hour (start infusion IMP or placebo) 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)

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Secondary

Measure	Time frame
Secondary end point(s): -Change in lactate (measured per 2 hour) -To determine ketanserin serum levels in retrospect. ;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) - At T=4 hr and T=8 hr a 6 ml blood sample will be drawn to determine ketanserin serum levels in retrospect.	—

Measure

Time frame

Secondary end point(s): -Change in lactate (measured per 2 hour) -To determine ketanserin serum levels in retrospect. ;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) - At T=4 hr and T=8 hr a 6 ml blood sample will be drawn to determine ketanserin serum levels in retrospect.

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Countries

Netherlands

Contacts

Public ContactIntensive Care Unit

OLVG

p.h.j.vandervoort@olvg.nl`00310205993007

Outcome results

None listed

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