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 deltaT.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
circulatie stoornissen bij intensive care patiënten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in DeltaT (measured per hour)
Secondary outcome
Change in lactate (measured per 2 hours)
Lactate clearance is calculated as described in chapter 2 of the protocol.
To calculate lactate clearance every two hours a 2 ml arterial blood sample for
lactate measurement will be collected (at T=0, T=2hr, T=4 hr, T=6 hr and T=8hr)
and sent for immediate analysis.
In addition, at T=4 hr and T=8 hr a 6 ml blood sample will be drawn to
determine ketanserin serum levels in retrospect.
Background summary
Rationale:
A high blood lactate and a high peripheral to central temperature difference
(deltaT) are associated with a higher mortality in critically ill patients
[Lima 2009, Bourcier 2016, Jansen 2010]. Both measures are signs of a reduced
microcirculatory bloodflow or vasoconstriction and are associated with shock
[Joly 1969,Lima 2009]. On the other hand, it has not been shown yet that
interventions leading to improvement of this temperature gap reduces mortality
or improves any other outcome measurement. Moreover, it is unknown which
medication can best be used to improve deltaT and lactate clearance.
Ketanserin is being used in the intensive care setting for decades to optimize
circulatory parameters. Ketanserin is a serotonin type 2-receptor blocker
(5-HT2). Blocking the 5-HT2 receptor with ketanserin can attenuate pathological
vasoconstriction. In these ways ketanserin can reduce vasoconstriction and can
improve the microcirculation. As a consequence, the enhanced blood flow in the
skin will increase the peripheral temperature and decrease deltaT. At the same
time an increased flow in the microcirculation may lead to a reduction in
lactate production
Study 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 deltaT.
Study design
A multicentre double blind randomized controlled trial.
Intervention
The intervention is a continuous pump driven Ketanserin infusion of 0.75
ug/kg/min for eight hours.
The control group will receive the same volume of glucose 5%.
Study burden and risks
The risks of ketanserin infusion are limited but can be a QTc prolongation and
a slight decrease in blood pressure. However, these effects seldomly occur
[Hoogstraaten 2014; van der Voort2017].
The study needs an arterial blood sample on inclusion, and after 2, 4, 6 and 8
hours of 1.5 ml each. In addition, a 6 ml blood sample at T=4 and T=8 hours.*
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003362-27-NL |
| CCMO | NL62916.100.17 |