Prehospital sepsis treatment with antibiotics in severe sepsis reduces mortality.
ID
Bron
Verkorte titel
Aandoening
sepsis
prehospital
pre-hospital
antibiotics
sepsis
prehospitaal
pre-hospitaal
antibiotica
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The reduction of mortality in patients with severe sepsis.
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
Prehospital sepsis treatment with antibiotics in severe sepsis reduces mortality.
Onderzoeksopzet
Date of enrollment of the first participant 1-11-2012.
The follow up is until discharge or death.
Onderzoeksproduct en/of interventie
The 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.
Algemeen / deelnemers
Albert Schweitzer hospital<br>
Postbus 444
E. Oskam
Dordrecht 3300 AK
The Netherlands
e.oskam@asz.nl
Wetenschappers
Albert Schweitzer hospital<br>
Postbus 444
E. Oskam
Dordrecht 3300 AK
The Netherlands
e.oskam@asz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Allergy for beta-lactam;
2. Age <18 jr.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3759 |
NTR-old | NTR3923 |
CCMO | NL37410.101.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON38203 |