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Pre-hospitale sepsis studie.


- candidate number14606
- NTR NumberNTR3923
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2013
- Secondary IDsNL37410.101.12 CCMO
- Public TitlePre-hospitale sepsis studie.
- Scientific TitlePre-hospital treatment of sepsis: Reduction in mortality in severe sepsis.
- ACRONYMPRESS
- hypothesisPrehospital sepsis treatment with antibiotics in severe sepsis reduces mortality.
- Healt Condition(s) or Problem(s) studiedSepsis, Antibiotics, Prehospital
- Inclusion criteria1. In the history signs of an infection;
2. Two of the following criteria: - Respitory Rate of > 20/min - Heart rate of > 90/min - A body temperature of > 38 degrees celsius or < 36 degrees celsius;
3. Lactate in veneus blood higher or equal to 2,5 mmol/lt.
- Exclusion criteria1. Allergy for beta-lactam;
2. Age <18 jr.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2012
- planned closingdate1-nov-2020
- Target number of participants2200
- InterventionsThe pre-hospital treatment group will receive 1,2 gr augmentin iv. within 30 minutes. The control group will receive no antibiotics. Before giving the augmentin, blood cultures will be taken.
- Primary outcomeThe reduction of mortality in patients with severe sepsis.
- Secondary outcome1. Prehospital treatment related to the organism, co-morbidity, co-medications, gender, age;
2. Comparison of the intervention group and control group with APACHE/NICE score.
- TimepointsDate of enrollment of the first participant 1-11-2012.
The follow up is until discharge or death.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E. Oskam
- CONTACT for SCIENTIFIC QUERIES E. Oskam
- Sponsor/Initiator Albert Schweitzer Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Albert Schweitzer Ziekenhuis, Dordrecht
- PublicationsN/A
- Brief summaryThe study is a randomized clinical trial. All ambulances are equiped with lactate scouts. When patients meet the inclusion criteria they will be randomised by particular envelop. The patients in the intervention group, without allergies, will receive augmentin 1,2 gr i.v. within 30 minutes. The controle group will receive no antibiotics. We expect to include 300 patients per year with severe sepsis into our study, devided in two groups. The date of mortality of both groups will be collected and compared when admitted to Albert Schweitzer hospital. The follow up is until discharge or death. The patients who are admitted to the ICU will be compared with the APACHE/NICE score. Objective of the studie: To give answers to the following questions: 1) Will prehospital treatment with augmentin 1,2 gr v.v.reduce the mortality in patients with severe sepsis? 2) What is the real percentage of septic patients who are suspected to have a severe sepsis in pre hospital phase? 3a) Is there a difference in lactate measurement after prehospital treatment and is it reliable? 3b) Is there a difference in blood cultures taken before and after the augmentin 1,2gr i.v.
- Main changes (audit trail)
- RECORD26-mrt-2013 - 6-apr-2013


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