Ketanserin effects on Peripheral Temperature and Lactate

Phase 4

Completed

Conditions: circulatie stoornissen bij intensive care patiënten
Microcirculatory failure

Registration Number: NL-OMON46490

Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

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

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in DeltaT (measured per hour)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in lactate (measured per 2 hours)<br /><br>Lactate clearance is calculated as described in chapter 2 of the protocol.<br /><br>To calculate lactate clearance every two hours a 2 ml arterial blood sample for<br /><br>lactate measurement will be collected (at T=0, T=2hr, T=4 hr, T=6 hr and T=8hr)<br /><br>and sent for immediate analysis.<br /><br><br /><br>In addition, at T=4 hr and T=8 hr a 6 ml blood sample will be drawn to<br /><br>determine ketanserin serum levels in retrospect. </p><br>