Cardiac Output, LowNCT02852941
Assessment of Volumetric Hemodynamic Parameters and Nutritional Status in Stable Renal Transplant Recipients
An observational study of Cardiac Output, Low and High Blood Pressure, 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 olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output, Low, High Blood Pressure
- What is being tested?
- CardioScreen 1000 and Tanita 418- Bioelectrical impedance analysis
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2016to Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 100 consecutive patients admitted to routine visin in Transplant Centre and 30 healthy subjects were included in this study.
Who may be able to join
- give voluntary consent to participate in the study
- functioning graft longer than 3 months to 10 years
- no clinical cardiovascular disease during the 6 months preceding entry
- stable graft function- glomerular filtration rate > 30 ml/min/1.73 m2, creatinine concentration <2.5 mg/dl
- medical staff (medical doctors, nurses)
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. Ilmenau) in stable renal transplant recipients Nutritional status was measured by Tanita 418 Monitor.
- Conditions
- Cardiac Output, Low, High Blood Pressure
- Being tested
- CardioScreen 1000, Tanita 418- Bioelectrical impedance analysis
- Keywords
- Impedance, Kidney Transplantation
- Medical subject headings
- Cardiac Output, Low, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioScreen 1000Device
Haemodynamic Measurement System, Medis Impedance cardiography (ICG)
Tanita 418- Bioelectrical impedance analysisDevice
The device measured the size of total body water (TBW), fat mass (FM%), visceral fat%, fat free mass (FFM), and basal metabolic rate (BMR) (kcal).
| Study group | Role | What they receive |
|---|---|---|
| Patients after kidney transplantation | The study included who had been admitted to a nephrology-transplantation outpatient clinic 0.5 to 30 years after kidney transplantation. Receives: Device: CardioScreen 1000; Device: Tanita 418- Bioelectrical impedance analysis | |
| Healthy subjects | Medical staff: medical doctors, nurses Receives: Device: CardioScreen 1000; Device: Tanita 418- Bioelectrical impedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of cardiac index in Stable Renal Transplant Recipients
Measurement of cardiac index (l/min/m2)
Measured: 1 day
Secondary outcomes (2)
Assessment of Nutritional Status in Stable Renal Transplant Recipients
Measurement of amount of fat tissue (%)
Measured: 1 day
Assessment of Systemic Vascular Resistance Index in Stable Renal Transplant Recipients
Measurement of Systemic Vascular Resistance Index (dynes-sec/cm-5/m2)
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 posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- 80 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852941
- Sponsor's protocol ID
- C.I/KTx/2016/07
- Status last verified
- Sep 2016
- First submitted
- 27 Jul 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Czyzewski L, Wyzgal J, Czyzewska E, Kurowski A, Sierdzinski J, Truszewski Z, Szarpak L. Assessment of Arterial Stiffness, Volume, and Nutritional Status in Stable Renal Transplant Recipients. Medicine (Baltimore). 2016 Feb;95(6):e2819. doi: 10.1097/MD.0000000000002819.
PubMed 26871855Czyzewski 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 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Volumetric Hemodynamic Parameters and Nutritional Status in Stable Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT02852941
- Acronym / sponsor ID
- C.I/KTx/2016/07
- Conditions
- Cardiac Output, Low, High Blood Pressure
- Keywords
- Impedance, Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Aug 2016 (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. Ilmenau) in stable renal transplant recipients Nutritional status was measured by Tanita 418 Monitor.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after kidney transplantation | – | Device: CardioScreen 1000, Device: Tanita 418- Bioelectrical impedance analysisThe study included who had been admitted to a nephrology-transplantation outpatient clinic 0.5 to 30 years after kidney transplantation. |
| Healthy subjects | – | Device: CardioScreen 1000, Device: Tanita 418- Bioelectrical impedance analysisMedical staff: medical doctors, nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 100 consecutive patients admitted to routine visin in Transplant Centre and 30 healthy subjects were included in this study.
Key inclusion criteria (5 listed)
- give voluntary consent to participate in the study
- functioning graft longer than 3 months to 10 years
- no clinical cardiovascular disease during the 6 months preceding entry
- stable graft function- glomerular filtration rate > 30 ml/min/1.73 m2, creatinine concentration <2.5 mg/dl
- medical staff (medical doctors, nurses)
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 1000Haemodynamic Measurement System, Medis Impedance cardiography (ICG) | Device | Healthy subjects, Patients after kidney transplantation |
| Tanita 418- Bioelectrical impedance analysisThe device measured the size of total body water (TBW), fat mass (FM%), visceral fat%, fat free mass (FFM), and basal metabolic rate (BMR) (kcal). | Device | Healthy subjects, Patients after kidney transplantation |
Primary outcome
Assessment of cardiac index in Stable Renal Transplant Recipients
Time frame: 1 day
Measurement of cardiac index (l/min/m2)
2 secondary outcomes
Assessment of Nutritional Status in Stable Renal Transplant Recipients
Time frame: 1 day
Assessment of Systemic Vascular Resistance Index in Stable Renal Transplant Recipients
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 13 Sep 2016.
- Background: PubMed 26871855Czyzewski L, Wyzgal J, Czyzewska E, Kurowski A, Sierdzinski J, Truszewski Z, Szarpak L. Assessment of Arterial Stiffness, Volume, and Nutritional Status in Stable Renal Transplant Recipients. Medicine (Baltimore). 2016 Feb;95(6):e2819. doi: 10.1097/MD.0000000000002819.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Output, Low and High Blood Pressure, 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 13 Sep 2016. 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?
Assessment of cardiac index in Stable Renal Transplant Recipients (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 NCT02852941, which also lists 4 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 13 Sep 2016.