Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration

NCT02264522 | Completed

• 1 other identifier: 04-14-39
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use the photo-plethysmographic \[PPG\] waveform signal to guide the dialysis and ultrafiltration \[UF\] of chronic maintenance hemodialysis patients, and to further the investigators understanding of homeostasis in hemodialysis. The investigators hypothesize that the signals generated from the PPG device along with traditional monitoring and nursing judgment, will allow experienced, oriented staff to anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic hypotention \[IDH\], forestalling the onset of non-facilitating compensatory reflexes that preclude the patient from achieving an appropriate post-dialysis weight consistent with euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to wean patients from anti-hypertensive medications and craft patient specific dialysis orders and UF profiles that achieve consistent, comfortable treatment to appropriate end points. The study aims include: Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine hemodialysis. Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to reverse the cardiovascular stress indicated by the PPG and to maintain perfusion. Aim 4: To develop care paths approved by the medical staff and primary care nephrologist allowing RNs to respond to signals from the PPG.

Conditions

Intradialytic Hypotension; Hypervolemia

Outcome Measures

Primary Outcomes (1)

• Difference between prescribed dry weight and actual measured weight at end of dialysis session.

  Percent difference between prescribed dry weight and actual weight at end of dialysis session.

  8 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

All patients will be enrolled in the same intervention arm. Interventions are implemented based in 1-4 event levels on the device. Interventions include: "Place dialysis chair into position 3", "Decrease dialysate temperature", "Decrease ultrafiltration rate by 25%", and "Decrease ultrafiltration rate by 50%".

Other: Place dialysis chair into position 3.; Other: Decrease dialysate temperature.; Other: Decrease ultrafiltration rate by 25%.; Other: Decrease ultrafiltration rate by 50%.

Interventions

Place dialysis chair into position 3. OTHER

Upon device notification event 1, place patient in dialysis chair position 3.

Single Arm

Decrease dialysate temperature. OTHER

Upon device notification event 2, decrease dialysate temperature by 0.5 degree centigrade.

Single Arm

Decrease ultrafiltration rate by 25%. OTHER

Upon device notification event 3, decrease ultrafiltration rate by 25% from baseline ultrafiltration rate.

Single Arm

Decrease ultrafiltration rate by 50%. OTHER

Upon device notification event 4, decrease ultrafiltration rate by 50% from baseline ultrafiltration rate.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• On dialysis \> 6 months with a stable dialysis program
• Consistent achievement of a spKt/V ≥ 1.2
• HGB ≥ 10 gm% ± ESA support
• Consistent failure to achieve a post weight ≤ dry weight + 0.5Kg
• Able to give informed consent directly
• Frequent hypotensive reactions (≥ 1 / treatment in 4 of last 8 treatments)
• Symptoms of hypotension
• Intervention administered because of IDH (saline, "turn downs, early termination, trendelenberg position)
• Drop in BP irrespective of symptoms. SBP \< 90 mmHG intra or post HD if pre SBP was \> 110 mmHG; SBP \< 85 mmHG or 15 mmHG drop from start if starting BP ≤ 110 mmHG.
• Or judged by the nursing staff to be difficult to achieve dry weight.

You may not qualify if:

• Cognitive Impairment precluding cooperation, and consent
• Restless or unlikely to wear the monitor head-band
• Too unstable in the judgment of their nephrologist to be included in a study of this nature.

Sponsors & Collaborators

• Intelomed, Inc.: lead
• Centers for Dialysis Care, Inc: collaborator

Study Sites (1)

Centers for Dialysis Care - East

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)