Primary: To determine the effects of MIH on circulatory, inflammatory and metabolic aspects of host response to sepsis.Secondary: To determine if MIH prevents and/or decreases the severity of ICU-AW in septic shock.
ID
Source
Brief title
Condition
- Body temperature conditions
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Metabolism: Mitochondrial 02 consumption
Circulation: Sublingual microcirculatory flow index
Inflammation: Total amount of circulating microparticles
Lung injury: total protein and inflammation markers in NBL
Secondary outcome
ICU-AW: MRC score
Background summary
In the CASS study, the main focus lies on clinical parameters of organ
dysfunction in septic shock patients treated with mild induced hypothermia
(MIH). This is also the case in other studies researching body temperature
regulation and sepsis in humans. However, unravelling the mechanistic pathways
of mild induced hypothermia in humans is imperative in our understanding the
potential therapeutic effects of MIH. This substudy of the CASS study aims to
elucidate the effects of regulating body temperature on circulatory,
inflammatory and metabolic aspects of host response to sepsis. These changes
also form the pathophysiologic basis for the development of intensive
care-acquired weakness (ICU-AW).
Study objective
Primary: To determine the effects of MIH on circulatory, inflammatory and
metabolic aspects of host response to sepsis.
Secondary: To determine if MIH prevents and/or decreases the severity of ICU-AW
in septic shock.
Study design
Randomized, single-blinded multicenter trial.
Patients included in the CASS study will be asked to participate in this
substudy. The patients will be subjected to several extra measurments.
For the purpose of whole blood stimulation, healthy controls will be recruited.
Study burden and risks
For patients there are no direct benefits for participation in this study. The
results of this study will result in a better understanding of the therapeutic
effects of MIH. The additional burden and risks for patients participating in
the substudies is minimal. In addition to routine blood samples we will to take
an extra 28 ml of blood on study day 1 and 28 on study day 3 (or at discharge).
These samples will be taken from arterial lines that are already in place
causing no additional discomfort to the patient. NBL's are frequently done at
our ICU and are part of standard airway care. The risk of this procedure is
small .The clinical measurements we will perform are minimally invasive, not
painful and are partially done while the patient is sedated minimizing patient
burden. Muscle strength scoring is standard of care in our department and will
be done once the patient is awake.
A total amount of 24 ml of blood will be taken from each healthy individual.
Meibergdreef 9
Amsterdam 1015AZ
NL
Meibergdreef 9
Amsterdam 1015AZ
NL
Listed location countries
Age
Inclusion criteria
Patients who have been included in the CASS trial
Healthy volunteers: 18 years or older
Exclusion criteria
- No informed consent for the substudy
- A platelet count < 10 x 10^9 /L
- Known mitochondrial disease
- Patient received platelet transfusion less than 6 hours before blood samples are taken
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49182.018.14 |