Objective of this study is to provide evidence for the induction of AGEs in blood and tissue in patients with septic shock.
ID
Source
Brief title
Condition
- Immune disorders NEC
- Ancillary infectious topics
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Survival rate in patients with severe septic shock and relationship with AGEs
2. Relationship of AGEs as measured in tissue, blood and as measured using the
autofluorescence reader.
3. Relationship between sublingual microcirculation (and reversibility) and
multi organ failure in septic patients.
Secondary outcome
1. Relationship between AGEs and capillary permeability in patients with sepsis
2. Relationship between AGEs and oxidative stress.
Background summary
Sepsis is characterized by the a severe inflammatory response. This
inflammatory response is responsible for the develepment of organ dysfunction.
Treatment aimed at this inflammatory response may reduce the mortality
associated with the multiple organ failure. AGEs are a diverse class of
compounds induced by an inflammatory response. The induction of AGEs was
previously thought to occur slowly over weeks to months, but recent data
indicate that AGEs can also occur during acute inflammatory conditions.
Investigating this response in patients with sepsis may provide the possibility
to influence the inflammatory response via this pathway.
Study objective
Objective of this study is to provide evidence for the induction of AGEs in
blood and tissue in patients with septic shock.
Study design
Prospective observational study with matched control group in which sublingual
orthogonal polarization spectral imaging (OPS) is used to measure the
microcirculation.
Study burden and risks
Obtaining skin biopsies is performed under local anesthesia. In addition,
patients with severe sepsis are sedated and giving intravenous anesthetics as
standard treatment. The extent of the burden of this skin biopsy (4 mm) is
experienced as minimal-moderate by patients who have undergone this procedure
in previous studies (MEC 98/10/172, METc 2001-233c, METc 2001-193, METc
2004.239). The other samples can be obtained with no extra burden or risks
(blood sampling using an already placed intra-arterial line and
autofluorescence is measured non-invasively). The injection of NaF can induce a
temporarily discoloration of the skin, but this effect dissappears within 10
minutes.
The OPS measurement obtain no extra burden or risks for the patients.
Postbus 616
6200 MD, mAASTRICHT
Nederland
Postbus 616
6200 MD, mAASTRICHT
Nederland
Listed location countries
Age
Inclusion criteria
1. Written informed consent from close relative
2. Age > 18 years
3. Patient meets the general criteria for severe sepsis or septic shock, diagnosed less than 24 h prior to study inclusion.
4. and patients meets the general criteria for pneumonia.
5. Systemic arterial catheter in place with continuous pressure monitoring.
6. Patients in whom the clinician is prepared to provide full life support during the duration of the study.
Exclusion criteria
1. Shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury etc.)
2. Liver cirrhosis
3. (Insulin-dependent) diabetes mellitus
4. Patients on dialysis (CVVH or other)
5. Pre-existent urea cycle disorders or renal failure
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 | NL14501.068.06 |