Effect of Fluid Resuscitation and Microcirculation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01369524
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : June 9, 2011
Information provided by:
Medical Centre Leeuwarden

Brief 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.

Condition or disease
Total Fluid Volume Increased

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

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effect of Fluid Resuscitation on Sublingual Microcirculation by SDF Imaging in Intensive Care Patients, a Pilot Study
Study Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : May 2011

ICUpatient with need of fluid
age > 18 - haemodynamic monitoring - informed consent - admission on ICU

Primary Outcome Measures :
  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 Outcome Measures :
  1. change in capillary density correlated to fluid responsiveness [ Time Frame: 24 hours ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • no informed consent
  • oral surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01369524

Medical Centre Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Sponsors and Collaborators
Medical Centre Leeuwarden
Principal Investigator: Christiaan Boerma, MD Medical Centre Leeuwarden

Responsible Party: Dr E.C. Boerma, Medical Centre Leeuwarden Identifier: NCT01369524     History of Changes
Other Study ID Numbers: TPO 732
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: May 2011

Keywords provided by Medical Centre Leeuwarden:
fluid responsiveness
Intensive Care