Hypoxemia in Maintenance Hemodialysis Patients

NCT03045796 | Unknown

• 1 other identifier: 17117
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  1 week, 3 Hemodialysis Treatments: Patients will be tested during their three regularly schedule hemodialysis treatment sessions in a one week.

Study Arms (1)

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

Interventions

Oxygen Saturation measured by WristOx DEVICE

Patients will be hooked up to finger cuffs as well as ECGs to monitor oxygen saturations in different part of the body.

Maintenance Hemodialysis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Maintenance Hemodialysis Patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Renal Research Institute: collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gwen Derk

CONTACT

805-797-9496; gderk2@illinois.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: February 8, 2017
• Study Start: March 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 11, 2017

Record last verified: 2016-11

Locations

US (1)