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Ketanserin Effects on Peripheral Temperature and Lactate (KoPTaL)
NCT03646318Phase 4
Key facts
- Status
- Unknown
- Start
- Sep 2018
- Primary completion
- Apr 2019
- Sponsor
- OLVG
- Modality
- Small Molecules
- Drugs
- ketanserin
- Conditions
- critical illness
01
Overview
Phase 4, randomised, double-blind trial in critical illness comparing Ketanserin Arm with Placebo Arm (2 arms). Primary endpoint: Delta Temperature at 8 hours. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ketanserin Arm
Continuous ketanserin infusion for 8 hours.
Placebo Arm
Continuous glucose 5% infusion for 8 hours.
03
Who it enrols
Critically ill adult patients with a peripheral-to-central temperature difference (deltaT) greater than 6.0°C.
04
Endpoints
Primary
Delta Temperature
Secondary
Lactate clearance
Hospital length of stay
Mortality
ICU length of stay
ICU mortality
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