Effect of Fluid Resuscitation and Microcirculation

Total Fluid Volume Increased Clinical Trial

Official title:

Evaluation of Effect of Fluid Resuscitation on Sublingual Microcirculation by SDF Imaging in Intensive Care Patients, a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369524
• Other study ID #: TPO 732
• Status: Completed
• Phase: N/A
• First received: May 31, 2011
• Last updated: June 8, 2011
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18

• hemodynamic monitoring

• informed consent

• admission on ICU

Exclusion Criteria:

• no informed consent

• oral surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Total Fluid Volume Increased

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between change in microvascular flow index and fluid responsiveness - delta MFI before and after fluid challenge correlated to fluid responsiveness		24 hours	No
Secondary	change in capillary density correlated to fluid responsiveness		24 hours	No