To examine the effect of surgical trauma on mucosal perfusion, intestinal epithelial damage, the inflammatory response and potentially sepsis, following surgery remote to the abdomen in adults, children and neonates,
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As first outcome measurement, this study will evaluate the origin of intestinal
epithelial cell damage, mucosal hypoperfsuion, inflammation, bacterial
translocation and postoperative complications. Complications will be defined as
the presence of SIRS, sepsis, or evidence of organ failure based on
internationally accepted biochemical and/or clinical criteria. We will
correlate the increase of studied plasma and urinary markers for intestinal
epithelial cell damage and inflammation with the occurence of post-operative
morbidity and complications.
The peak levels of studied markers will be correlated with the amount of
hypoperfusion, measured by gastric tonometry. The release of intestinal cell
damage and inflammation markers will be correlated with the amount of blood
loss, duration and extension of surgery.
Secondary outcome
Secondary outcome measurements will consist of duration of intensive care unit
stay, postoperative onset of feeding, use of antibiotics.
Background summary
Children undergoing major surgery often develop systemic inflammatory response
syndrome (SIRS) and sepsis. Patients with SIRS and sepsis have an increased
risk of developing multiple organ failure (MOF), which is the leading cause of
death in surgical patients.
We hypothesize that surgical stress, such as blood loss causing splanchnic
hypoperfusion, in combination with the inflammation caused by significant
tissue trauma, leads to intestinal epithelial damage. Subsequently, the loss of
normal intestinal barrier function leads to translocation of bacteria causing
SIRS and possibly sepsis.
Because newborns, children and adults have a different bacterial colonization
of the intestinal tract and the immune system matures only during childhood, we
hypothesize to find different intestinal and inflammatory responses during and
after surgery in these age groups. Therfore, the study evaluates whether there
is any difference in gut damage and inflammatory response between adult,
pediatric and neonatal surgical populations.
Study objective
To examine the effect of surgical trauma on mucosal perfusion, intestinal
epithelial damage, the inflammatory response and potentially sepsis, following
surgery remote to the abdomen in adults, children and neonates,
Study design
The study will be a longitudinal, observational study of adults, children and
neonates undergoing major non-abdominal surgery. In adults and children we will
study patients that undergo scoliosis repair surgery. In neonates we will study
patients undergoing thoracotomy. All patients will subsequently be admitted to
ICU, PICU or NICU respectively. In neonates we will sample urine. In adults and
children we will only sample blood. We will obtain an initial blood or urinary
sample upon induction of anesthesia before surgery commences. Subsequent plasma
respectively urine sampling will occur every two hours after the start of
surgery, 2 hours after wound closure, and then daily for at least 48 hours. A
gastric tonometry catheter will be introduced for measurement of intramucosal
CO2 pressure in children and adults.
To study intestinal cell damage we will use I-FABP, ILBP and L-FABP. To study
inflammation we will use neutrophil activation product, complement activation
and the cytokine response. To study splanchnic hypoperfusion we will perform
gastric tonometry.
Study burden and risks
A total of 18 ml and 36 ml of blood will be sampled from respectively children
and adults over a time period of 48 hours.
Blood will be sampled from either an arterial or central venous line intra- and
immediately post-operatively, and then concurrent with the normal daily blood
testing post-operatively.
In neonates we will collect 1 ml urine every 2 hours during surgery and 2, 12,
24 and 48 hours postoperatively. Urine will be sampled from a CAD, which will
be placed at any case before start of surgery.
A gastric tonometry catheter will be introduced after aneasthesia for
measurement of intramucosal CO2 pressure during surgery in children and adults.
Blood/ urine sampling and gastric tonometry do not bring an extra risk for the
patient.
Patients do not directly benefit but all patients that will undergo major
surgery in the future will.
Universiteitssingel 50
6229 ER
Nederland
Universiteitssingel 50
6229 ER
Nederland
Listed location countries
Age
Inclusion criteria
Children and adults undergoing major spinal surgery and neonates undergoing thoracotomy in the University Hospital Maastricht.
Patients that have an arterial line or central venous access to facilitate plasma
sampling.
Patients that have given informed consent
Exclusion criteria
Patients who have any other cause for gut damage, such as inflammation (eg active inflammatory bowel disease), direct surgical trauma (eg abdominal surgery), or artificial circulation (eg cardiopulmonary bypass).
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 | NL12209.068.06 |