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Hypoxemia in Maintenance Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT03045796
Recruitment Status : Unknown
Verified November 2016 by University of Illinois at Urbana-Champaign.
Recruitment status was:  Recruiting
First Posted : February 8, 2017
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Renal Research Institute
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

Brief 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. 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.


Condition or disease Intervention/treatment
Oxygen Saturation and the Relationship to Other Cardiac Variables Maintenance Hemodialysis Kidney Failure, Chronic Device: Oxygen Saturation measured by WristOx

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Output and Central-Venous Oxygen Saturation in Maintenance Hemodialysis Patients
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: Oxygen Saturation measured by WristOx
Patients will be hooked up to finger cuffs as well as ECGs to monitor oxygen saturations in different part of the body.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Maintenance Hemodialysis Patients
Criteria

Inclusion Criteria:

  1. Age 18 years and able to give written informed consent to the study
  2. Central Venous Catheter (CVC) used for vascular access
  3. Participants must receive hemodialysis treatment at least 3 days per week.
  4. 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.
  5. 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.

Exclusion Criteria:

  1. Scheduled renal transplantation during the study
  2. Active infection requiring ongoing antibiotics or antivirals
  3. Simultaneous participation in another clinical study with potential impact on cardiovascular/hemodynamic parameters

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045796


Contacts
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Contact: Gwen Derk 805-797-9496 gderk2@illinois.edu

Locations
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United States, Illinois
University of Illinois at Urbana-Champaign Recruiting
Urbana, Illinois, United States, 61801
Contact: Kenneth R Wilund, PhD    217-265-6755    kwilund@illinois.edu   
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Renal Research Institute

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03045796    
Other Study ID Numbers: 17117
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: November 2016
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic