Microcirculation in Continuous Venovenous Hemofiltration Patients on the Intensive Care Unit

Continuous Venovenous Hemofiltration Clinical Trial

Official title:

Evaluation of Sublingual Microcirculation by Means of SDF Imaging by Stepwise Ultrafiltration in CVVH Patients on the ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362088
• Other study ID #: TPO 767
• Status: Completed
• Phase: N/A
• First received: May 11, 2011
• Last updated: October 31, 2012
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• 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

In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate, the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number, the microvascular flow index (MFI).

Description:

Before deciding to threat a patient actively with CVVH, a target balance will be agreed for the next 12 hours. Then the ultrafiltration rate for the zero balance is calculated. From there, the ultrafiltration rate progressively increased to 50 ml per hour, up to a maximum ultrafiltration rate of 300 ml per hour.

After each increase of the ultrafiltration rate, the sublingual microcirculation is assessed by SDF.

After obtaining the desired ultrafiltration rate, the microcirculation will again be assessed before and after the patient is temporarily placed in Trendelenburg position. This could possibly show that underfill has the greatest influence on the microcirculation, and not other factors like a rising hematocrit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 jaar

• informed consent

Exclusion Criteria:

• age < 18 jaar

• oral surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Continuous Venovenous Hemofiltration

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, 

References & Publications (1)

Bemelmans RH, Boerma EC, Barendregt J, Ince C, Rommes JH, Spronk PE. Changes in the volume status of haemodialysis patients are reflected in sublingual microvascular perfusion. Nephrol Dial Transplant. 2009 Nov;24(11):3487-92. doi: 10.1093/ndt/gfp267. Epub 2009 Jun 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in MFI between zero balance and maximal ultrafiltrationrate (300 ml/hr)		4 hours	No