Effect of Fluid Resuscitation and Microcirculation

This study has been completed.
Sponsor:
Information provided by:
Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT01369524
First received: May 31, 2011
Last updated: June 8, 2011
Last verified: May 2011
  Purpose

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
Total Fluid Volume Increased

Study Type: Observational
Study Design: 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

Further study details as provided by Medical Centre Leeuwarden:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in capillary density correlated to fluid responsiveness [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICUpatient with need of fluid
age > 18 - haemodynamic monitoring - informed consent - admission on ICU

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients admitted on the ICU and a need of fluids

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent
  • oral surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01369524

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

No publications provided

Responsible Party: Dr E.C. Boerma, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT01369524     History of Changes
Other Study ID Numbers: TPO 732
Study First Received: May 31, 2011
Last Updated: June 8, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Centre Leeuwarden:
fluid responsiveness
microcirculation
Intensive Care

ClinicalTrials.gov processed this record on August 28, 2014