|- candidate number||14606|
|- NTR Number||NTR3923|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mrt-2013|
|- Secondary IDs||NL37410.101.12 CCMO|
|- Public Title||Pre-hospitale sepsis studie.|
|- Scientific Title||Pre-hospital treatment of sepsis: Reduction in mortality in severe sepsis.|
|- hypothesis||Prehospital sepsis treatment with antibiotics in severe sepsis reduces mortality.|
|- Healt Condition(s) or Problem(s) studied||Sepsis, Antibiotics, Prehospital|
|- Inclusion criteria||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.
|- Exclusion criteria||1. Allergy for beta-lactam;|
2. Age <18 jr.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2012|
|- planned closingdate||1-nov-2020|
|- Target number of participants||2200|
|- Interventions||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. |
|- Primary outcome||The reduction of mortality in patients with severe sepsis. |
|- Secondary outcome||1. 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.
|- Timepoints||Date of enrollment of the first participant 1-11-2012. |
The follow up is until discharge or death.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| E. Oskam|
|- CONTACT for SCIENTIFIC QUERIES|| E. Oskam|
|- Sponsor/Initiator ||Albert Schweitzer Ziekenhuis |
(Source(s) of Monetary or Material Support)
|Albert Schweitzer Ziekenhuis, Dordrecht |
|- Brief summary||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. |
|- Main changes (audit trail)|
|- RECORD||26-mrt-2013 - 6-apr-2013|