Complication of HemodialysisNCT01396980
Microcirculation During Haemodialysis
An observational study of Complication of Hemodialysis, run by Frisius Medisch Centrum at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Hemodialysis
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable hemodialysis patients with dialysis dependancy for more than 3 months, with adequate access
Who may be able to join
- dialysis patient
- age > 18
- informed consent
Who cannot join
- no adequate access
- instable hemodynamics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Microcirculatory Flow Measurements During Haemodialysis in Relation to Blood Volume Change
- 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).
Read the 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
- Keywords
- hemodialysis, intensive care, microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dialysis patients | dialysis patients, stabil, dialysis dependancy for more than 3 months, with adequate access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between sublingual microvascular flow index between 2 types of ultrafiltration
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.C. Boerma, Frisius Medisch Centrum
- Investigators
- Christiaan Boerma, MD, Principal investigator, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396980
- Sponsor's protocol ID
- TPO 776
- Status last verified
- Feb 2012
- First submitted
- 31 May 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28219329
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Microcirculatory Flow Measurements During Haemodialysis in Relation to Blood Volume Change
- ClinicalTrials.gov ID
- NCT01396980
- Acronym / sponsor ID
- TPO 776
- Conditions
- Complication of Hemodialysis
- Keywords
- hemodialysis, intensive care, microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dialysis patients | – | –dialysis patients, stabil, dialysis dependancy for more than 3 months, with adequate access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable hemodialysis patients with dialysis dependancy for more than 3 months, with adequate access
Key inclusion criteria (3 listed)
- dialysis patient
- age > 18
- informed consent
Key exclusion criteria (2 listed)
- no adequate access
- instable hemodynamics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between sublingual microvascular flow index between 2 types of ultrafiltration
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Derived from this study: PubMed 28219329Veenstra 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.
Related trials for Complication of Hemodialysis
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Pruritus, Chronic Kidney Diseases
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Not yet recruitingPhase 3
Ramipril vs. Amlodipine in Pediatric Hemodialysis Patients
Endothelial Dysfunction, End-Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiaan Boerma, MD principal investigator
Frisius Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Hemodialysis, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between sublingual microvascular flow index between 2 types of ultrafiltration (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01396980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.