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| [ Print-friendly version ] |
| The effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute stroke: a phase II double-blind randomised placebo-controlled trial |
| ISRCTN | ISRCTN98608690 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute stroke: a phase II double-blind randomised placebo-controlled trial |
| Scientific title | |
| Acronym | PISA |
| Serial number at source | N/A |
| Study hypothesis | To study the effect of high-dose ibuprofen and to confirm the previously observed reducing effect of high-dose paracetamol on body temperature, and to study their safety in normothermic and subfebrile patients with acute ischaemic stroke. |
| Ethics approval | The medical ethics committees of the three hospitals have approved this protocol. |
| Study design | Randomised controlled trial |
| Countries of recruitment | The Netherlands |
| Disease/condition/study domain | Stroke |
| Participants - inclusion criteria |
1. An acute ischaemic anterior circulation stroke
2. A body temperature greater than 36.0°C or less than 39.0°C 3. A CT scan that is compatible with acute ischaemic stroke 4. A focal deficit without rapid improvement 5. A possibility to start treatment within 24 hours after stroke onset |
| Participants - exclusion criteria |
1. Severe aphasia, defined as an aphasia score of 2 or 3 on the National Institutes of Health Stroke Scale (NIHSS)
2. Treatment with an non-Steroidal Anti-Inflammatory Drug (NSAID) deemed necessary 3. Hypersensitivity to ibuprofen or paracetamol 4. (Chronic) liver failure or cirrhosis 5. (Chronic) renal failure 6. History of alcohol abuse 7. Active gastric ulcer disease or a history of peptic ulceration or gastro-intestinal haemorrhage in the preceding year 8. Colitis ulcerosa 9. Pregnancy 10. Use of corticosteroids 11. A severe concomitant medical condition that could affect the assessment of the effect of the study medication on temperature 12. Residual neurological impairment resulting from a previous stroke that may hamper the assessment of functional outcome 13. Death appearing imminent 14. No informed consent given |
| Anticipated start date | 01/12/2000 |
| Anticipated end date | 31/12/2001 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 75 |
| Interventions |
1. Paracetamol 6 g daily, for 5 days
2. Ibuprofen 2.4 g daily, for 5 days 3. Placebo for 5 days |
| Primary outcome measure(s) | Body temperature at 24 hours from start of treatment. |
| Secondary outcome measure(s) |
1. Change in baseline temperature at 1 and 5 days from start of treatment
2. Time with elevated body temperature (greater than 37.0°C) (area under the curve) during the first 24 hours and the first five days Tertiary outcomes: Functional outcome at one month, as determined by the scores on the modified Rankin Scale (mRS) and Barthel Index (BI). |
| Sources of funding | Rotterdam Neurovascular Research Foundation (Stichting Neurovasculair Onderzoek Rotterdam) (The Netherlands) |
| Trial website | |
| Publications |
Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11918829
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=12657165 |
| Contact name | Dr Diederik WJ Dippel |
| Address |
Dept of Neurology
University Hospital Rotterdam PO Box 2040 |
| City/town | Rotterdam |
| Zip/Postcode | 3000 CR |
| Country | Netherlands |
| Tel | +31 (0)10 4639222 |
| Fax | +31 (0)10 4089446 |
| dippel@neuro.fgg.eur.nl | |
| Sponsor | Erasmus Medical Center (The Netherlands) |
| Address | P.O. Box 1738 |
| City/town | Rotterdam |
| Zip/Postcode | 3000 DR |
| Country | Netherlands |
| Sponsor website: | http://www.erasmusmc.nl/content/englishindex.htm |
| Date applied | 15/02/2002 |
| Last edited | 06/09/2007 |
| Date ISRCTN assigned | 15/02/2002 |
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