Recruiting

Observational Study

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT03045796

Conditions

Oxygen Saturation and the Relationship to Other Cardiac Variables

Maintenance Hemodialysis

Kidney Failure, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Oxygen Saturation measured by WristOx

Study Details

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.

Conditions

Oxygen Saturation and the Relationship to Other Cardiac Variables

Maintenance Hemodialysis

Kidney Failure, Chronic

Study ID

NCT03045796

Start date

Mar 1, 2017

Status verified date

Nov, 2016

Completion date

Jan, 2018

Anticipated

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Gwen Derk

805-797-9496gderk2@illinois.edu

Locations

University of Illinois at Urbana-Champaign

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Kenneth R Wilund, PhD

217-265-6755kwilund@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

May 11, 2017

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2017-05-11.