Microcirculation During Haemodialysis

Completed

• Conditions: Complication of Hemodialysis

• Registration Number: NCT01396980
• Lead Sponsor: Medical Centre Leeuwarden

Brief 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).

Detailed 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)

Study Timeline

• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Study Start: 2011-09
• Primary Completion: 2012-01
• Status Verified: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• dialysis patient
• age > 18
• informed consent

Exclusion Criteria

• no adequate access
• instable hemodynamics

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between sublingual microvascular flow index between 2 types of ultrafiltration	3 weeks

Trial Locations

Locations (1)

Medical Centre Leeuwarden; 🇳🇱 Leeuwarden, Netherlands