We hypothesize that treatment of patients with acute ischemic or hemorrhagic stroke and a body temperature of 36,5°C or above with paracetamol in a daily dose of 6 g for three consecutive days, leads to improved functional outcome. At least 50%…
ID
Bron
Verkorte titel
Aandoening
acute stroke, cerebral infarction, intracraniel hemorrhage, acetaminophen, body temperature, inflammation, functional outcome
herseninfarct, hersenbloeding, paracetamol, lichaamstemperatuur, inflammatie, functionele uitkomst
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
A favorable outcome defined as improvement on the modified Rankin Scale (mRS) at 3 months from stroke onset.
Achtergrond van het onderzoek
In the Paracetamol (Acetaminophen) in Stroke (PAIS) trial, a double-blind, placebo-controlled randomized clinical trial of 1400 patients with acute stroke, the paracetamol-treated patients (6 g daily, 3 days) showed more improvement on the modified Rankin scale (mRS) at 3 months, yet the difference was not statistically significant. In the 661 patients with a baseline body temperature of 36,5°C or above, treatment with paracetamol led to a larger decrease in temperature (0.30°C; 95% CI: 0.20-0.40), increased the odds of improvement (OR 1.43; 95% CI: 1.02-1.97) and was associated with a 7% (95% CI: 0-15%, p=0.06) absolute decrease in the risk of poor outcome. These findings need further study.
Doel van het onderzoek
We hypothesize that treatment of patients with acute ischemic or hemorrhagic stroke and a body temperature of 36,5°C or above with paracetamol in a daily dose of 6 g for three consecutive days, leads to improved functional outcome.
At least 50% of patients with acute stroke have a body temperature over 36,5°C. Increased body temperature is related to poor functional outcome. The risk of poor outcome may double with each degree Celsius increase in body temperature.
Onderzoeksopzet
1. Oktober 2010: first inclusion;
2. Juli 2014: final inclusion;
3. Oktober 2014: end of follow-up.
Onderzoeksproduct en/of interventie
Paracetamol or matching placebo will be administered 6 times daily for three consecutive days; the first 24 hours as suppositories of 1 g, or as 2 tablets of 500 mg per dosage (after swallowing difficulties have been excluded), from 24-72 hours as 2 tablets of 500 mg per dosage.
Algemeen / deelnemers
Inger Ridder, de
Rotterdam 3015 GE
The Netherlands
+31 (0)10 7040704
i.deridder@erasmusmc.nl
Wetenschappers
Inger Ridder, de
Rotterdam 3015 GE
The Netherlands
+31 (0)10 7040704
i.deridder@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Clinical diagnosis of ischemic stroke or intracerebral hemorrhage, confirmed by CT or MRI scan within 24 hours after inclusion in the study;
2. A measurable deficit on the National Institutes of Health Stroke Scale (NIHSS);
3. The possibility to start treatment within 12 hours of symptom onset (for patients who noticed symptoms when awaking from sleep, the time last seen well is taken as the time of onset of symptoms);
4. A body temperature of 36,5°C or higher;
5. Age of 18 years or older;
6. Signed informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. A body temperature lower than 36.5°C;
2. A history of liver disease or alcohol abuse;
3. Liver enzymes (ASAT, ALAT, AP or gamma-GT) increased above twice the upper limit of normal values;
4. Allergy to paracetamol;
5. Death appearing imminent at the time of inclusion;
6. Any pre-stroke impairment that has led to dependency (modified Rankin scale (mRS)>2) and therefore interferes with the assessment of functional outcome.
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 | NL2239 |
| NTR-old | NTR2365 |
| Ander register | WHO UTN : U1111-1124-9185 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |