Microcirculation During Haemodialysis | NCT01396980

Studies
Microcirculation During Haemodialysis

NCT01396980

Sponsor

Frisius Medisch Centrum

Status

Completed

Last Update Posted

Feb 22, 2012Estimated

Enrollment

8Actual

Phase

Not provided

Conditions

Complication of Hemodialysis

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

May 31, 2011

First Submission Date that Met QC Criteria

Jul 18, 2011

First Posted Date

Jul 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2012

Last Update Posted Date

Feb 22, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dialysis patients		dialysis patients, stabil, dialysis dependancy for more than 3 months, with adequate access

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference between sublingual microvascular flow index between 2 types of ultrafiltration		3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

dialysis patient
age > 18
informed consent

Exclusion Criteria:

no adequate access
instable hemodynamics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christiaan Boerma, MD	Frisius Medisch Centrum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Centre Leeuwarden		Leeuwarden		8934 AD	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28219329	Derived	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.