- Primary Objective: to investigate whether the administration of a small amount of dobutamine postoperatively is able to positively influence the sublingual microcirculation in patients who are undergoing esophagectomy.- Secondary Objective: to…
ID
Source
Brief title
Condition
- Gastrointestinal vascular conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The aim of our study is to observe the postoperative sublingual microvascular
perfusion changes in functional capillary density (FCD), perfused vessel
density (PVD) and microvascular flow index (MFI), in patients undergoing
esophagectomy and the effect of dobutamine intravenously.
Secondary outcome
To observe the effect of low dose dobutamine on heart rate and cardiac output.
Background summary
Typical complications of esophagectomy and gastric tube reconstruction
include leakage and stenosis from the anastomosis of the neck, which may be due
to the compromises microvascular blood flow (MBF). Recently Jhanji et al.
showed that MBF can be of predictive value for the postoperative course: those
with a disturbed postoperative microvascular perfusion have more postoperative
complications. In another study a similar predictive phenomenon was seen in
patients with septic shock. The patients who ultimately died from the shock,
had a worse microcirculation in the first 24 hours, than those who survived the
shock. Administration of dobutamine in these patients improved the
microvascular perfusion, independent of global hemodynamic parameters. It is
therefore important to investigate how the postoperative microcirculation
behaves in patients undergoing esophagectomy with gastric tube reconstruction,
and if this can positively be influenced by giving a low dose dobutamine.
Study objective
- Primary Objective: to investigate whether the administration of a small
amount of dobutamine postoperatively is able to positively influence the
sublingual microcirculation in patients who are undergoing esophagectomy.
- Secondary Objective: to observe what effect postoperative administration of
dobutamine has on cardiac output, postoperative morbidity, IC- and hospital
stay
Study design
This study is designed as a prospective double blind randomized controlled
trial.
Intervention
Patients who are undergoing an esophagectomy with gastric tube reconstrucion
are randomised in 2 groups; patients with and without intravenous
administration of low dose dobutamine during the first 2 postoperative days.
Study burden and risks
The microvascular perfusion is observed in all patients by placing a small
handheld camera, SDF-camera gently under the tongue. This Sidestream Dark Field
(SDF) imager is a new and more improved method to observe the subliungual
microcirculation at bedside, see page 12 of the protocol for more explanation.
The observation is not painful or invasive. By placing the camera at the mucosa
under the tongue a good image can be made of the microvascular perfusion. This
measurement takes place once a day for a total of 4 days. Each measurement
approximately takes 25-30 min. Patients who are classified in the intervention
group will immediately be connected to a postoperative intravenous dobutamine
pump. This will remain connected to 2 days postoperatively. This represents no
additional burden for the patient because the patient won*t notice anything due
to the anesthesia of the. No additional lines have to be punctured.
A side effect of dobutamine is that it can cause tachycardia. The chance of
this is however very small, because the dose used in this study is at most half
of the normally effective dose used in the IC. In addition, the administration
can immediately be stopped with a half life time of 2 min. In previous studies
with dobutamine good results are seen in the sublingual microvascular
perfusion. Therefore we expect a good improvement of the microvascular
perfusion.
's-gravendijkwal 230
3015 CE Rotterdam
NL
's-gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Age range: > 18 years
- ASA classification I - III
- Written informed consent
- Elective esophagectomy
Exclusion criteria
- Age range: < 18 years
- ASA classification IV and V
- Diabetes Mellitus (bad microvessels)
- Administration of drugs with positive inotropic effects
- Patients with previous cardiac events (previous cardiac arrests and
arrythmia)
- Informed written consent missing
Design
Recruitment
Medical products/devices used
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 |
---|---|
EudraCT | EUCTR2009-015949-23-NL |
CCMO | NL29699.078.09 |
OMON | NL-OMON26013 |