Microcirculation During Haemodialysis

NCT ID: NCT01396980

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-02-29

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)

Conditions

Complication of Hemodialysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

dialysis patients

dialysis patients, stabil, dialysis dependancy for more than 3 months, with adequate access

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• dialysis patient
• age > 18
• informed consent

Exclusion Criteria

• no adequate access
• instable hemodynamics

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frisius Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

E.C. Boerma

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christiaan Boerma, MD

Role: PRINCIPAL_INVESTIGATOR

Frisius Medisch Centrum

Locations

Medical Centre Leeuwarden

Leeuwarden, , Netherlands

Countries

Netherlands

References

Veenstra G, Pranskunas A, Skarupskiene I, Pilvinis V, Hemmelder MH, Ince C, Boerma EC. Ultrafiltration rate is an important determinant of microcirculatory alterations during chronic renal replacement therapy. BMC Nephrol. 2017 Feb 20;18(1):71. doi: 10.1186/s12882-017-0483-z.

Reference Type: DERIVED

PMID: 28219329 (View on PubMed)

Other Identifiers

TPO 776

Identifier Type: -

Identifier Source: org_study_id