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CompletedNCT01369524Updated Jun 9, 2011

Effect of Fluid Resuscitation and Microcirculation

An observational study in Total Fluid Volume Increased, sponsored by Medical Centre Leeuwarden. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-09.

Sponsored by Medical Centre Leeuwarden · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

Although the investigators take many measurements to monitor the fluid state of the patients, it is not known exactly whether the fluid has real effect on the organ perfusion. The main focus of fluid is to improve the organ perfusion. Recent research has focused on the investigation of sublingual microcirculatory alterations.

Read the detailed description

Is fluid responsiveness, what means a better cardiac output, equal to the need for fluid for a better organ perfusion? In hospital the investigators are now looking to the pump function of the heart, as there is not a better measurement. However this gives no information about necessity of giving fluids. A healthy volunteer also gives a better pump function of the heart after fluid, but that fluid is not necessary and gives no better organ perfusion. The question is: How many percent of the patients have a MFI score of \< 2.6, when the doctor on clinical basis plans to give fluid to the patient, improves organ perfusion after fluid, and is this correlated with an improvement of the cardiac output All intensive care patients who need extra fluid are eligible for this study. Before and after the fluid challenge we do SDF imaging sublingual. Per patient the investigators do this 1x in 24 hours. Concurrently, data on both patient characteristics (e.g. severity of illness) will be obtained Study population max 100 patients. Possible outcome: MFI \< 2,6 en SV > 10% + MFI up MFI \< 2,6 en SV equal + MFI equal MFI \< 2,6 en SV > 10% + MFI equal MFI \< 2,6 en SV equal + MFI up MFI > 2,6 en SV > 10% + MFI up MFI > 2,6 en SV equal + MFI equal MFI > 2,6 en SV > 10% + MFI equal MFI > 2,6 en SV equal + MFI up

02

Conditions studied

  • Total Fluid Volume Increased

Keywords

  • fluid responsiveness
  • microcirculation
  • Intensive Care
03

In context

Lead sponsor

Medical Centre Leeuwarden is the lead sponsor of 41 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients admitted on the ICU and a need of fluids

Inclusion criteria

  • age > 18
  • hemodynamic monitoring
  • informed consent
  • admission on ICU

Exclusion criteria

Exclusion Criteria:

  • no informed consent
  • oral surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)

Groups and cohorts

  • ICUpatient with need of fluid

    age \> 18 - haemodynamic monitoring - informed consent - admission on ICU

06

What researchers measure

Primary outcomes

  1. correlation between change in microvascular flow index and fluid responsiveness - delta MFI before and after fluid challenge correlated to fluid responsiveness

    Time frame: 24 hours

Secondary outcomes

  1. change in capillary density correlated to fluid responsiveness

    Time frame: 24 hours

07

Study locations

1 site
  • Medical Centre Leeuwarden
    Leeuwarden, 8934 AD, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01369524
Lead sponsor
Medical Centre Leeuwarden
First posted
Jun 9, 2011
Start date
Jan 2011
Primary completion
Mar 2011
Completion
May 2011
Last update
Jun 9, 2011

Study contacts

Christiaan Boerma, MD
principal investigator · Medical Centre Leeuwarden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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