Oxygen Saturation and the Relationship to Other Cardiac VariablesNCT03045796
Hypoxemia in Maintenance Hemodialysis Patients
An observational study of Oxygen Saturation and the Relationship to Other Cardiac Variables and Maintenance Hemodialysis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
Previous research has shown that many patients with kidney failure undergoing chronic hemodialysis (HD) have a very low venous oxygen concentration, which may further decrease during dialysis treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation and the Relationship to Other Cardiac Variables, Maintenance Hemodialysis, Kidney Failure, Chronic
- What is being tested?
- Oxygen Saturation measured by WristOx
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to Jan 2018
- 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: Maintenance Hemodialysis Patients
Who may be able to join
- Age 18 years and able to give written informed consent to the study
- Central Venous Catheter (CVC) used for vascular access
- Participants must receive hemodialysis treatment at least 3 days per week.
- Participants must be on hemodialysis treatment longer than 3 months. Patients on dialysis treatment for < 3 months will be excluded, or have their enrollment postponed, due to physiological changes that typically occur at the onset of dialysis.
- Participants must have a central-venous catheter as their vascular access site for dialysis, as our aim is to measure venous oxygen concentrations. Patients with A-V fistula's or grafts will be excluded because we are not interested in collecting arterial oxygen concentrations.
Who cannot join
- Scheduled renal transplantation during the study
- Active infection requiring ongoing antibiotics or antivirals
- Simultaneous participation in another clinical study with potential impact on cardiovascular/hemodynamic parameters
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
Kenneth R Wilund, PhD, 217-265-6755, kwilund@illinois.edu
About this study
Official title: Cardiac Output and Central-Venous Oxygen Saturation in Maintenance Hemodialysis Patients
Previous research has shown that many patients with kidney failure undergoing chronic hemodialysis (HD) have a very low venous oxygen concentration, which may further decrease during dialysis treatments. This may be due to a variety of factors including anemia, compromised pulmonary function, and chronic fluid volume overload. Previous studies have shown that low venous oxygen concentrations may increase the risk of cardiovascular events, cognitive deficits, and mortality in HD patients.
The purpose of this study is to identify patients with hypoxemia during HD treatments and characterize the extent of and implications of their hypoxemia. Specifically, the investigators aim to examine the relationship between central venous oxygen concentration and hemodynamic changes during dialysis treatment. The investigators will evaluate the relationship between cardiac output as measured by the Task Force Monitor and central venous oxygen saturation as measured by the Crit-Line Monitor and Wrist0x2 in HD patient. Data from this study will provide insight into potential mechanisms responsible for side effects associated with dialysis treatment, such as drops in blood pressure and cognitive dysfunction.
Read the detailed description
Following the initial recruitment, all individuals who are willing to participate and sign the informed consent document will be provided with a medical history form to complete. In addition, the investigators will ask participants to sign a HIPAA authorization form in order to look into their medical records for monthly blood work (blood chemistry), anthropometric data (height and weight), interdialytic weight gain (weight gain since last treatment) history, and current medications.
Testing DURING all study protocol days:
Testing will be performed on three consecutive dialysis days during a one-week period (Monday/ Wednesday/Friday or Tuesday/Thursday/Saturday). If a data collection period is missed for any reason, an alternative data collection day will be scheduled. All three study visits are identical with respect to the study procedures performed:
- Hemodynamics: The hemodynamic response to dialysis will be obtained using the Task Force Monitor (TFM). The TFM will be connected to the subject prior the start of the HD session. The TFM is a non-invasive device that uses thoracic bioimpedance to collect a variety of data related to cardiovascular function, including: Heart Rate Variability: Beat-to-beat heart rate (HR) will be recorded using the Task Force Monitor. The ECG will be collected online at a sampling rate of 1,000 Hz, in real time, and stored on a computer (Dell, Austin, TX). Heart rate and the variability of the intervals between successive heart rates will be derived from the ECG signal. Beat-to-Beat Blood Pressure: Beat-to-beat peripheral BP will be derived via finger plethysmography (Task Force Monitor). A finger cuff will be placed around the non-dialyzing index and middle finger. These cuffs measure the change in blood pressure from successive beats continuously. Cardiac Output: Cardiac output and stroke volume will be collected by the task force monitor. An electrode will be placed around the chest to measure changes in impedance continuously. Blood Pressure: Blood pressure will be measured before the start and every 10 minutes throughout the session using an automated cuff connected to the TFM. The cuff will be placed on the non-dialyzing arm of the patient. The continuous non-invasive arterial pressure (CNAP) technology on the TFM machine will also be performed continuously during 10 minute segments every hour until the end of the HD treatment (i.e. from minute 0 to 10, 60 to 70, 120 to 130, 180 to 190). The TFM will measure these hemodynamic values continuously throughout the entire HD session.
- Relative Blood Volume and Hematocrit: The Critline is a regular part of dialysis treatment at the Champaign Urbana clinic. The Critline non-invasively measures hematocrit, relative blood volume, and oxygen saturation in real time. A trained staff member of the Champaign Urbana Dialysis Clinic will add a disposable blood chamber to the dialysis machine. As blood travels through this chamber hematocrit and oxygen saturation are measured by the absorbance and scattering of light. The hematocrit value is then used to estimate the blood volume relative to the start of the dialysis session.
- The Wrist0x2 will be connected prior to the HD session and measurements will be recorded continuously throughout the entire HD session.
- Clinic Factors: The investigators will gather some information collected by the clinic including: participant weight gain since the previous treatment, the volume of fluid removed during the treatment, the composition of the dialysate used during the treatment, and the rate of flow of both the blood and dialysate through the hemodialysis machine during the treatment.
- Lab Values: The investigators will also obtain results from monthly blood chemistries run on patient's blood samples by the clinic in the month prior to participant enrollment. These values will include but are not limited to information such as serum albumin, phosphorus, and calcium.
After completion of the HD treatment, the patient will be disconnected from the TFM and Wrist0x2.
- Conditions
- Oxygen Saturation and the Relationship to Other Cardiac Variables, Maintenance Hemodialysis, Kidney Failure, Chronic
- Being tested
- Oxygen Saturation measured by WristOx
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen Saturation measured by WristOxDevice
Patients will be hooked up to finger cuffs as well as ECGs to monitor oxygen saturations in different part of the body.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Hemodialysis Patients | Following the initial recruitment, all individuals who are willing to participate and sign the informed consent document will be provided with a medical history form to complete. In addition, we will ask them to sign a HIPAA authorization form in order to look into their medical records for monthly blood work (blood chemistry), anthropometric data (height and weight), interdialytic weight gain (weight gain since last treatment) history, and current medications. Receives: Device: Oxygen Saturation measured by WristOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamics
The hemodynamic response to dialysis will be obtained using the Task Force Monitor (TFM). The TFM will be connected to the subject prior the start of the HD session. The TFM is a non-invasive device that uses thoracic bioimpedance to collect a variety of data related to cardiovascular function, including: heart rate variability, beat-to-beat blood pressure, cardiac output, blood pressure.
Measured: 1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.
Relative Blood Volume and Hematocrit
The Critline is a regular part of dialysis treatment at the Champaign-Urbana clinic. The Critline non-invasively measures hematocrit, relative blood volume, and oxygen saturation in real time. A trained staff member of the Champaign-Urbana Dialysis Clinic will add a disposable blood chamber to the dialysis machine. As blood travels through this chamber hematocrit and oxygen saturation are measured by the absorbance and scattering of light. The hematocrit value is then used to estimate the blood volume relative to the start of the dialysis session.
Measured: 1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.
Oxygen Saturation
The Wrist0x2 will be connected prior to the HD session and measurements will be recorded continuously throughout the entire HD session.
Measured: 1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.
Lab Values
We will also obtain results from monthly blood chemistries run on patient's blood samples by the clinic in the month prior to participant enrollment. These values will include but are not limited to information such as serum albumin, phosphorus, and calcium.
Measured: 1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Saturation and the Relationship to Other Cardiac VariablesStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Renal Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045796
- Sponsor's protocol ID
- 17117
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 11 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output and Central-Venous Oxygen Saturation in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03045796
- Acronym / sponsor ID
- 17117
- Conditions
- Oxygen Saturation and the Relationship to Other Cardiac Variables, Maintenance Hemodialysis, Kidney Failure, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Renal Research Institute
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 8 Feb 2017 (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.
Previous research has shown that many patients with kidney failure undergoing chronic hemodialysis (HD) have a very low venous oxygen concentration, which may further decrease during dialysis treatments. This may be due to a variety of factors including anemia, compromised pulmonary function, and chronic fluid volume overload. Previous studies have shown that low venous oxygen concentrations may increase the risk of cardiovascular events, cognitive deficits, and mortality in HD patients.
The purpose of this study is to identify patients with hypoxemia during HD treatments and characterize the extent of and implications of their hypoxemia. Specifically, the investigators aim to examine the relationship between central venous oxygen concentration and hemodynamic changes during dialysis treatment. The investigators will evaluate the relationship between cardiac output as measured by the Task Force Monitor and central venous oxygen saturation as measured by the Crit-Line Monitor and Wrist0x2 in HD patient. Data from this study will provide insight into potential mechanisms responsible for side effects associated with dialysis treatment, such as drops in blood pressure and cognitive dysfunction.
Detailed description
Following the initial recruitment, all individuals who are willing to participate and sign the informed consent document will be provided with a medical history form to complete. In addition, the investigators will ask participants to sign a HIPAA authorization form in order to look into their medical records for monthly blood work (blood chemistry), anthropometric data (height and weight), interdialytic weight gain (weight gain since last treatment) history, and current medications.
Testing DURING all study protocol days:
Testing will be performed on three consecutive dialysis days during a one-week period (Monday/ Wednesday/Friday or Tuesday/Thursday/Saturday). If a data collection period is missed for any reason, an alternative data collection day will be scheduled. All three study visits are identical with respect to the study procedures performed:
- Hemodynamics: The hemodynamic response to dialysis will be obtained using the Task Force Monitor (TFM). The TFM will be connected to the subject prior the start of the HD session. The TFM is a non-invasive device that uses thoracic bioimpedance to collect a variety of data related to cardiovascular function, including: Heart Rate Variability: Beat-to-beat heart rate (HR) will be recorded using the Task Force Monitor. The ECG will be collected online at a sampling rate of 1,000 Hz, in real time, and stored on a computer (Dell, Austin, TX). Heart rate and the variability of the intervals between successive heart rates will be derived from the ECG signal. Beat-to-Beat Blood Pressure: Beat-to-beat peripheral BP will be derived via finger plethysmography (Task Force Monitor). A finger cuff will be placed around the non-dialyzing index and middle finger. These cuffs measure the change in blood pressure from successive beats continuously. Cardiac Output: Cardiac output and stroke volume will be collected by the task force monitor. An electrode will be placed around the chest to measure changes in impedance continuously. Blood Pressure: Blood pressure will be measured before the start and every 10 minutes throughout the session using an automated cuff connected to the TFM. The cuff will be placed on the non-dialyzing arm of the patient. The continuous non-invasive arterial pressure (CNAP) technology on the TFM machine will also be performed continuously during 10 minute segments every hour until the end of the HD treatment (i.e. from minute 0 to 10, 60 to 70, 120 to 130, 180 to 190). The TFM will measure these hemodynamic values continuously throughout the entire HD session.
- Relative Blood Volume and Hematocrit: The Critline is a regular part of dialysis treatment at the Champaign Urbana clinic. The Critline non-invasively measures hematocrit, relative blood volume, and oxygen saturation in real time. A trained staff member of the Champaign Urbana Dialysis Clinic will add a disposable blood chamber to the dialysis machine. As blood travels through this chamber hematocrit and oxygen saturation are measured by the absorbance and scattering of light. The hematocrit value is then used to estimate the blood volume relative to the start of the dialysis session.
- The Wrist0x2 will be connected prior to the HD session and measurements will be recorded continuously throughout the entire HD session.
- Clinic Factors: The investigators will gather some information collected by the clinic including: participant weight gain since the previous treatment, the volume of fluid removed during the treatment, the composition of the dialysate used during the treatment, and the rate of flow of both the blood and dialysate through the hemodialysis machine during the treatment.
- Lab Values: The investigators will also obtain results from monthly blood chemistries run on patient's blood samples by the clinic in the month prior to participant enrollment. These values will include but are not limited to information such as serum albumin, phosphorus, and calcium.
After completion of the HD treatment, the patient will be disconnected from the TFM and Wrist0x2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance Hemodialysis Patients | – | Device: Oxygen Saturation measured by WristOxFollowing the initial recruitment, all individuals who are willing to participate and sign the informed consent document will be provided with a medical history form to complete. In addition, we will ask them to sign a HIPAA authorization form in order to look into their medical records for monthly blood work (blood chemistry), anthropometric data (height and weight), interdialytic weight gain (weight gain since last treatment) history, and current medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Maintenance Hemodialysis Patients
Key inclusion criteria (5 listed)
- Age 18 years and able to give written informed consent to the study
- Central Venous Catheter (CVC) used for vascular access
- Participants must receive hemodialysis treatment at least 3 days per week.
- Participants must be on hemodialysis treatment longer than 3 months. Patients on dialysis treatment for < 3 months will be excluded, or have their enrollment postponed, due to physiological changes that typically occur at the onset of dialysis.
- Participants must have a central-venous catheter as their vascular access site for dialysis, as our aim is to measure venous oxygen concentrations. Patients with A-V fistula's or grafts will be excluded because we are not interested in collecting arterial oxygen concentrations.
Key exclusion criteria (3 listed)
- Scheduled renal transplantation during the study
- Active infection requiring ongoing antibiotics or antivirals
- Simultaneous participation in another clinical study with potential impact on cardiovascular/hemodynamic parameters
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 |
|---|---|---|
| Oxygen Saturation measured by WristOxPatients will be hooked up to finger cuffs as well as ECGs to monitor oxygen saturations in different part of the body. | Device | Maintenance Hemodialysis Patients |
Primary outcome
Hemodynamics
Time frame: 1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.
The hemodynamic response to dialysis will be obtained using the Task Force Monitor (TFM). The TFM will be connected to the subject prior the start of the HD session. The TFM is a non-invasive device that uses thoracic bioimpedance to collect a variety of data related to cardiovascular function, including: heart rate variability, beat-to-beat blood pressure, cardiac output, blood pressure.
Relative Blood Volume and Hematocrit
Time frame: 1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.
The Critline is a regular part of dialysis treatment at the Champaign-Urbana clinic. The Critline non-invasively measures hematocrit, relative blood volume, and oxygen saturation in real time. A trained staff member of the Champaign-Urbana Dialysis Clinic will add a disposable blood chamber to the dialysis machine. As blood travels through this chamber hematocrit and oxygen saturation are measured by the absorbance and scattering of light. The hematocrit value is then used to estimate the blood volume relative to the start of the dialysis session.
Oxygen Saturation
Time frame: 1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.
The Wrist0x2 will be connected prior to the HD session and measurements will be recorded continuously throughout the entire HD session.
Lab Values
Time frame: 1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.
We will also obtain results from monthly blood chemistries run on patient's blood samples by the clinic in the month prior to participant enrollment. These values will include but are not limited to information such as serum albumin, phosphorus, and calcium.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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.
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 Oxygen Saturation and the Relationship to Other Cardiac Variables and Maintenance Hemodialysis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 11 May 2017. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwen Derk (805-797-9496, gderk2@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamics (time frame: 1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2017.