Early antipyretic therapy reduces the risk of death or dependency in patients with acute stroke, even if they are normothermic
ID
Bron
Verkorte titel
Aandoening
stroke
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure is the dichotomized mRS (¡Ü2: good outcome, ¡Ý3: poor outcome) at 3 months.
Achtergrond van het onderzoek
Subfebrile temperature and fever in the acute phase of stroke are associated with large infarct volumes, high case fatality and poor functional outcome. A 1ºC rise in body temperature may double the odds of poor outcome in patients who are admitted within 12 hours from onset of symptoms. Two pilot studies showed that high-dose paracetamol induces a decrease in body temperature of 0.3-0.4¡ãC in patients with acute ischemic stroke, even if they are normothermic. This effect occurs within 4 hours after the start of treatment. The purpose of PAIS is to assess whether this decrease in body temperature translates into better clinical outcomes.
Doel van het onderzoek
Early antipyretic therapy reduces the risk of death or dependency in patients with acute stroke, even if they are normothermic
Onderzoeksproduct en/of interventie
Treatment with high dose paracetamol (6 g/day) or placebo will start within 12 hours after onset of symptoms, and continue for 3 days.
Publiek
Department of Neurology, Suite Ee 2240
P.O. Box 2040
H. Hertog, den
Rotterdam 3000 CA
The Netherlands
+31(0)10 4639222
m.denhertog@erasmusmc.nl
Wetenschappelijk
Department of Neurology, Suite Ee 2240
P.O. Box 2040
H. Hertog, den
Rotterdam 3000 CA
The Netherlands
+31(0)10 4639222
m.denhertog@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Clinical diagnosis of acute stroke
2. Possibility to start treatment within 12 hours from onset
3. Brain CT or MRI within 24 hours
4. Age 18 years or older
5. Signed informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. A body temperature lower than 36 degrees Celsius or higher than 39 degrees Celsius
2. A history of liver disease
3. Alcohol abuse
4. Liver enzymes increased above twice the upper limit of normal
5. Allergy to paracetamol
6. Significant pre-stroke impairment (³3 on the modified Rankin Scale (mRS))
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL740 |
| NTR-old | NTR750 |
| Ander register | : N/A |
| ISRCTN | ISRCTN74418480 |
Samenvatting resultaten
PISA, Dippel, van Breda et al., BMC Cardiovascular Disorders, 2003
PAIS protocol, van Breda, van der Worp et al., BMC Cardiovascular Disorders, 2005