I) Is the infusion of crystalloid fluids in healthy subjects associated with a reduction in microcirculatory perfused vessel density and increase in perfused boundary region? II) Does colloid administration attenuates the crystalloid-induced…
ID
Source
Brief title
Condition
- Other condition
- Therapeutic procedures and supportive care NEC
Synonym
Health condition
Volumebelasting
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Microcirculatory perfused vessel density (PVD) and perfused boundary region
(PBR) measured using sublingual capillary videoscope imaging.
Secondary outcome
* Intraoperative administered fluid volume, fluid balance, urine output
* Microvascular Flow Index (MFI)
* Microvascular flow heterogeneity
* Hemodynamic parameters (blood pressure, heart frequency, pulse pressure
variation in mechanically ventilated patients, stroke volume, cardiac index.
Background summary
During anesthesia and surgery, patients receive fluids to maintain system
hemodynamics and to compensate for blood loss. Inadequate fluid resuscitation
in the intraoperative period may not only result in perioperative hypovolemia
or postoperative fluid overload, but may also change the integrity of the
vascular wall. Animal studies suggest that the glycocalyx serves as a competent
barrier for water and colloids, but may also be damaged by fluid infusion.
However, evidence for this phenomenon in patients is limited, which is mainly
due to the lack of measurement devices. With the introduction of a novel
technique for evaluation of microvascular changes it has recently become
possible to study glycocalyx dimensions in patients. In the present study we
will investigate the effects of a fluid challenge on microcirculatory vessel
perfusion and the glycocalyx thickness in order to gain more insight in the
effects of fluid therapy on microvascular perfusion and the perfused boundary
region.
Study objective
I) Is the infusion of crystalloid fluids in healthy subjects associated with a
reduction in microcirculatory perfused vessel density and increase in perfused
boundary region?
II) Does colloid administration attenuates the crystalloid-induced alterations
in the microcirculatory perfused vessel density and increase in perfused
boundary region in healthy subjects?
III) What is the relation between the volume of intraoperative fluid infusion
and the level of microcirculatory perfused boundary region in patients
undergoing surgery?
Study design
An intervention study in 19 healthy volunteers, and an observational study in
26 surgical patients in VU University Medical Center, Amsterdam, the
Netherlands.
Intervention
In healthy subjects, the intervention includes two fluid boluses (crystalloid
and colloid) of 300 ml each.
Study burden and risks
Healthy subjects: healthy subjects will be exposed to an intravenous punction,
two fluid boluses, 6 sublingual microcirculatory measurements and Nexfin
hemodynamic measurements, which are all associated with minimal discomfort.
Healthy subjects have no benefit from the present study.
Patients: Nexfin and microcirculatory measurements will be mostly performed
during anesthesia, and the burden for the patient is minimal. Intraoperative
fluid management is part of the standard anesthesia procedure. There are no
benefits from the present study for the patient.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Healthy subjects
* Age 18-85 years
* Normal renal function
* Normal liver function
Patients
* Age 18-85 years
* Normal renal function
* Normal liver function
Exclusion criteria
Healthy subjects
* Peripheral edema
* Cardiovascular disease (hypertension, myocardial ischemia, heart failure)
* Use of antihypertensive, diuretics
* Allergy to gelatines
* Severe asthma;Patients
* Peripheral edema
* Myocardial infarction, heart failure, renal replacement therapy
* Use of diuretics
* Previous chemotherapy
* Diabetes mellitus I or II with use of anti-diabetic medication
* User of steroids
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
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2013-002044-81-NL |
CCMO | NL44851.029.13 |