No registrations found.
ID
Source
Brief title
Health condition
stroke
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the dichotomized mRS (¡Ü2: good outcome, ¡Ý3: poor outcome) at 3 months.
Secondary outcome
Secondary endpoints are the score on the Barthel index after two weeks, body temperature after 24 hours of treatment, and the EuroQol-5D at 3 months.
Background summary
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.
Study objective
Early antipyretic therapy reduces the risk of death or dependency in patients with acute stroke, even if they are normothermic
Intervention
Treatment with high dose paracetamol (6 g/day) or placebo will start within 12 hours after onset of symptoms, and continue for 3 days.
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
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
Inclusion criteria
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
Exclusion criteria
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))
Design
Recruitment
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 |
|---|---|
| NTR-new | NL740 |
| NTR-old | NTR750 |
| Other | : N/A |
| ISRCTN | ISRCTN74418480 |
Summary results
PISA, Dippel, van Breda et al., BMC Cardiovascular Disorders, 2003
PAIS protocol, van Breda, van der Worp et al., BMC Cardiovascular Disorders, 2005