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

May 31, 2011
June 8, 2011
January 2011
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01369524 on ClinicalTrials.gov Archive Site
change in capillary density correlated to fluid responsiveness [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Fluid Resuscitation and Microcirculation
Evaluation of Effect of Fluid Resuscitation on Sublingual Microcirculation by SDF Imaging in Intensive Care Patients, a Pilot Study

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

All patients admitted on the ICU and a need of fluids

Total Fluid Volume Increased
Not Provided
ICUpatient with need of fluid
age > 18 - haemodynamic monitoring - informed consent - admission on ICU
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent
  • oral surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01369524
TPO 732
No
Dr E.C. Boerma, Medical Centre Leeuwarden
Medical Centre Leeuwarden
Not Provided
Principal Investigator: Christiaan Boerma, MD Medical Centre Leeuwarden
Medical Centre Leeuwarden
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP