Effect of Fluid Resuscitation and Microcirculation
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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 |
- 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 ]
- 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 |
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
Contacts and Locations
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 June 13, 2013