Microcirculation During Haemodialysis

Complication of Hemodialysis Clinical Trial

Official title:

Sublingual Microcirculatory Flow Measurements During Haemodialysis in Relation to Blood Volume Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396980
• Other study ID #: TPO 776
• Status: Completed
• Phase: N/A
• First received: May 31, 2011
• Last updated: February 20, 2012
• Start date: September 2011
• Est. completion date: February 2012

Study information

• Verified date: February 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

• SDF is validated by measuring changes in microcirculation in sepsis patients with MOF (Boerma studies).

• SDF is validated by measuring changes in microcirculation in stable chronic hemodialysis patients (NDT 2009 Bemelmans).

• Ultrafiltration in stable chronic hemodialysis leads to a decrease in sublingual microcirculatory flow (NDT 2009 Bemelmans).

• Trendelenburg position improves the sublingual microcirculatory flow at the end of hemodialysis treatment (NDT 2009 Bemelmans).

• Hemodialysis with ultrafiltration leads to a significant reduction of myocardial perfusion and cardiac output (NDT 2009 Dasselaar)

• Cardiac output measurement during dialysis is not practical.

• BVM is a validated method for hypotension due to ultrafiltration to prevent the amount of ultrafiltration online change based on the measured haemoconcentration (ref Dasselaar et al NDT 2005).

• BCM is a validated measurement to the dry weight in hemodialysis patients measured by a bioimpedance technique (NDT Passauer et al 2009).

Description:

The search for an optimal method of ultrafiltration with minimal hypoperfusion of vital organs.

• Stabile hemodialysis patients with dialysis dependancy for more than 3 months, with adequate access

• Study duration 3 weeks

• Number of hemodialysis treatment for purposes of study: 3

• Timing hemodialysis treatments for Study session Monday or Tuesday after the weekend (randomized design in the sessions)

• session a: 5 hours total duration: 4 hours HD without UF followed by 1 hour GUF

• Session b: 4 hours total duration: 4 hours HD with UF

• session c: 4 hours total duration: 4 hours HD with UF and BVM

• UF is determined by actual target weight.

• Measurements during sessions:

• In each session in advance: blood pressure, pulse, weight, BCM, laboratory tests (Hb, Hct, Na, K, urea, creatinine, calcium, albumin, phosphate, nt-proBNP, troponin T, CRP)

• During each session at t = 0, t = 1 hour, t =2 hours and t = 4 hours: SDF, blood pressure, pulse, UF at that time, UF rate at that time

• End each session: blood pressure, pulse, weight, BCM, laboratory tests (Hb, Hct, Na, K, urea, creatinine, calcium, albumin, phosphate, nt-proBNP, troponin T, CRP)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• dialysis patient

• age > 18

• informed consent

Exclusion Criteria:

• no adequate access

• instable hemodynamics

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complication of Hemodialysis

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	Difference between sublingual microvascular flow index between 2 types of ultrafiltration		3 weeks	No