End Stage Renal Failure on DialysisCI/HDNCT02485782
Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis
An observational study of End Stage Renal Failure on Dialysis and Body Fluid Retention, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis, Body Fluid Retention, Impedance
- What is being tested?
- CardioScreen 1000 - Haemodynamic Measurement System, Medis, BCM- Body Composition Monitor, Fresenius Medical Care and SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2015to Sep 2015
- 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: A total of 80 consecutive patients on maintenance hemodialysis were included in this study.
Who may be able to join
- give voluntary consent to participate in the study
- patients on maintenance hemodialysis at least 3 months
- stable dry weight
- single-pool Kt/V >1.4
- no clinical cardiovascular disease during the 6 months preceding entry
Who cannot join
- not meet the above criteria
- episode of illness (for example: infection)
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau) beginning 15 min prior to midweek dialysis session and continuous measurement thereafter, with a 15-min period after the termination of hemodialysis. Fluid overload were measured by BCM Monitor Fresenius before hemodialysis.
- Being tested
- CardioScreen 1000 - Haemodynamic Measurement System, Medis, BCM- Body Composition Monitor, Fresenius Medical Care, SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioScreen 1000 - Haemodynamic Measurement System, MedisDevice
Impedance cardiography (ICG)
BCM- Body Composition Monitor, Fresenius Medical CareDevice
Information about the individual fluid status and the nutritional status.
SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring SystemDevice
Blood pressure monitoring every 15 min during hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | * midweek dialysis session
* patients on maintenance hemodialysis at least 3 months
* stable dry weight
* single-pool Kt/V >1.4
* no clinical cardiovascular disease during the 6 months preceding entry Receives: Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis; Device: BCM- Body Composition Monitor, Fresenius Medical Care; Device: SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on hemodialysis.
Measured: 1 day
Secondary outcomes (4)
Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on hemodialysis.
Measured: 1 day
Changes in volumetric hemodynamic parameter- systemic vascular resistance [dyn·s·cm-5] induced by fluid removal on hemodialysis.
Measured: 1 day
Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during hemodialysis.
Measured: 1 day
Changes in blood pressure values [mmHg] induced by fluid removal on hemodialysis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies 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
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Czyżewski, Medical University of Warsaw
- Investigators
- Janusz Wyzgał, Professor, Study chair, Medical University of Warsaw, Department of Nephrologic Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485782
- Sponsor's protocol ID
- C.I/HD/2015/06
- Acronym
- CI/HD
- Status last verified
- Sep 2015
- First submitted
- 26 Jun 2015
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248.
PubMed 25365639Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189.
PubMed 24770703Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265.
PubMed 25382249
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis
- ClinicalTrials.gov ID
- NCT02485782
- Acronym / sponsor ID
- CI/HD / C.I/HD/2015/06
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Jun 2015 (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.
Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau) beginning 15 min prior to midweek dialysis session and continuous measurement thereafter, with a 15-min period after the termination of hemodialysis. Fluid overload were measured by BCM Monitor Fresenius before hemodialysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis, Device: BCM- Body Composition Monitor, Fresenius Medical Care, Device: SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System* midweek dialysis session * patients on maintenance hemodialysis at least 3 months * stable dry weight * single-pool Kt/V >1.4 * no clinical cardiovascular disease during the 6 months preceding entry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 80 consecutive patients on maintenance hemodialysis were included in this study.
Key inclusion criteria (5 listed)
- give voluntary consent to participate in the study
- patients on maintenance hemodialysis at least 3 months
- stable dry weight
- single-pool Kt/V >1.4
- no clinical cardiovascular disease during the 6 months preceding entry
Key exclusion criteria (3 listed)
- not meet the above criteria
- episode of illness (for example: infection)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioScreen 1000 - Haemodynamic Measurement System, MedisImpedance cardiography (ICG) | Device | Hemodialysis patients |
| BCM- Body Composition Monitor, Fresenius Medical CareInformation about the individual fluid status and the nutritional status. | Device | Hemodialysis patients |
| SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring SystemBlood pressure monitoring every 15 min during hemodialysis | Device | Hemodialysis patients |
Primary outcome
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on hemodialysis.
Time frame: 1 day
4 secondary outcomes
Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on hemodialysis.
Time frame: 1 day
Changes in volumetric hemodynamic parameter- systemic vascular resistance [dyn·s·cm-5] induced by fluid removal on hemodialysis.
Time frame: 1 day
Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during hemodialysis.
Time frame: 1 day
Changes in blood pressure values [mmHg] induced by fluid removal on hemodialysis.
Time frame: 1 day
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 Sep 2015.
- Background: PubMed 25365639Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248.
- Background: PubMed 24770703Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189.
- Background: PubMed 25382249Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265.
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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.
Janusz Wyzgał, Professor study chair
Medical University of Warsaw, Department of Nephrologic Nursing
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 End Stage Renal Failure on Dialysis and Body Fluid Retention, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 3 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 Sep 2015. 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 Poland. 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?
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on hemodialysis. (time frame: 1 day). 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 NCT02485782, which also lists 3 linked publications.
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 Sep 2015.