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…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The reduction of mortality in patients with severe sepsis.
Secondary outcome
Prehospital treatment related to the organism, co-morbidity, co-medications,
gender, age.
Comparison of the intervention group and control group with APACHE/NICE score.
Background summary
Sepsis can be defined as the body's response to an infection. An infection is
caused by micro organisms or "germs" (usually bacteria) invading the body, and
can be limited to a particular body region (eg, a tooth abscess) or can be
widespread in the bloodstream (often called "septicemia" or "blood
poisoning"). Sepsis is a medical emergency just like a heart attack or a
stroke because there is an interruption of oxygen and nutrients to the tissues
including the vital organs such as the brain, intestines, liver, kidneys and
lungs.
The surviving sepsis campaign was launched in 2002. In 2004 the surviving
sepsis campaign initially produced evidence based guidelines for management of
severe sepsis, these were updated in 2008. The primairy goal of the campaign
was to reduce the mortality with 25% .
Since in our hospital the implementation of the sepsis criteria all patients
with severe sepsis admitted to the ICU were drawn bloodcultures and received
antibiotics on the ED.
Robson et al stated in their article the significant contribution of the EMS in
treatment of patients with acute coronary syndrome, multiple trauma and stroke.
They considered in their article that prehospital staff can improve the outcome
of patients with severe sepsis. They concluded that there is a need for further
exploration on this field.
The primary goal of this research is to explore if prehospital antibiotics will
reduce mortality in patients with severe sepsis..
Study objective
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.
Study design
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 200 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.
Intervention
The prehospital 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.
Study burden and risks
Because the prehospital treatment of severe sepsis with antibiotics will be the
same as in hospital, we will not expect more complications in the study
population.
Albert Schweitzerplaats 25
Dordrecht 3300 AK
NL
Albert Schweitzerplaats 25
Dordrecht 3300 AK
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL37410.101.12 |
OMON | NL-OMON29015 |