search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Sublingual microvascular changes in perfused vessel density and boundary region during an intravenous fluid challenge


- candidate number16989
- NTR NumberNTR4468
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mrt-2014
- Secondary IDsANES 2013/01 
- Public TitleSublingual microvascular changes in perfused vessel density and boundary region during an intravenous fluid challenge
- Scientific TitleSublingual microvascular changes in perfused vessel density and boundary region during an intravenous fluid challenge
- ACRONYMCHALLENGE study
- hypothesisThis study will investigate the effects of a fluid challenge on microcirculatory vessel perfusion and the glycocalyx thickness. It is hypothesized that infusion of crystalloid fluids in healthy subjects is associated with a volume-dependant reduction in microcirculatory perfused vessel density and an increase in perfused boundary region due to effects of cristalloid fluid loading. Besides, an attenuation of cristalloid-induced alterations in microcirculatory perfused vessel density and perfused boundary region by colloid administration is hypothesized.
- Healt Condition(s) or Problem(s) studiedMicrocirculation
- Inclusion criteriaHealthy volunteers (n=19): Age 18-85 years, normal renal function, normal liver function Patients (n=26) undergoing elective abdominal surgery under general anesthesia, age 18-85 years, normal renal function, normal liver function
- Exclusion criteriaHealthy volunteers: Peripheral edema Cardiovascular disease (hypertension, myocardial ischemia, heart failure) Allergy to gelatines Use of antihypertensive, diuretics 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate30-aug-2015
- Target number of participants45
- InterventionsHealthy volunteers: Subjects are first exposed to a bolus of crystalloid fluid (300 ml), which is followed by a bolus of colloid fluid (gelofusine) (300 ml). Before and after fluid administration, the microcirculatory perfused vessel density and perfused boundary region are monitored using sublingual Capiscope imaging. Subjects are hemodynamically monitored using Nexfin continuous blood pressure measurements. The study ends after the last sublingual microcirculatory measurement. Patients: Anesthetized patients who are exposed to 500 ml crystalloid or colloid fluids (gelofusine) are monitored using sublingual Capiscope imaging to gain insight in the relation between the fluid balance and microcirculatory perfusion. Before and after fluid administration, the microcirculatory perfused vessel density and perfused boundary region are monitored using sublingual Capiscope imaging. Subjects are hemodynamically monitored using Nexfin continuous blood pressure measurements. The study ends after the surgical procedure has been completed.
- Primary outcomeMicrocirculatory perfused vessel density (PVD) and perfused boundary region (PBR) measured using sublingual Capiscope imaging.
- Secondary outcomeIntraoperative 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).
- TimepointsHealthy volunteers: 2 hours study period Patients: duration of anesthesia
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Christa Boer
- CONTACT for SCIENTIFIC QUERIESDr. Christa Boer
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summaryDuring 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.
- Main changes (audit trail)
- RECORD25-mrt-2014 - 19-apr-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl