Observational Study to Assess Oxygen Saturation Predictive Power Related to Intradialytic Acute Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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The aim of the present work was to analyze the short-term variability of SO2 during hemodialysis in sessions with and without hypotension to correlate the SO2 variability to hemodynamic instability.

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Detailed Description

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During the last 40 years a lot has been achieved in dialysis regarding both monitors safety and membranes overall performances Anyway, intradialytic symptoms still remain a major concern for nephrologists: in particular, hypotension is the most frequent \[1\].

Intradialytic hemodynamic monitoring systems have been developed to have continuous surveillance of the main hemodynamic variables (heart rate, body temperature, blood pressure itself, cardiac output, ecc…).

In a second moment, the further evolution was towards the retroactive control systems, to force some of the variables involved in the genesis of the hemodynamic stability, along a pre-determined, ideal, trend. In this view, various bio-feedback mechanisms have been proposes along the years, for example, to tackle hypovolemia-related hypotension. Their scientific rationale is the control of either blood volume or directly natremia, in order to pilot plasma refilling towards the vascular compartment \[2\].

Despite the great achievements obtained, the forecasting of acute hypotension during hemodialysis still remains a complex problem, likely involving more than one variable.

SO2 can be considered an indirect expression of the hemodynamic stability. Moreover, in dialysis, it has always been regarded as a bio-compatibility marker for membranes \[3\]. Nowadays, SO2 changes during dialysis are easy to measure with a fully, non-invasive sensor assembled on the arterial line.

We planned this study to analyze on a large number of sessions the short-term variability of SO2 during hemodialysis in relationship with hemodynamic tolerance.

Conditions

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Acute Intradialytic Hypotension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypotension-prone patients

The study group included all patients treated with standard HD prone to acute intradialytic hypotension.

Hypotension-prone patients

Intervention Type DEVICE

Hemox optical sensor equips the dialysis monitors used during this trial. It is able to measure continuously, on arterial blood line, oxygen saturation, hematocrit and blood volume reduction.

Interventions

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Hypotension-prone patients

Hemox optical sensor equips the dialysis monitors used during this trial. It is able to measure continuously, on arterial blood line, oxygen saturation, hematocrit and blood volume reduction.

Intervention Type DEVICE

Other Intervention Names

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Hemox

Eligibility Criteria

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Inclusion Criteria

* Dialysis vintage \> 6 months
* Well functioning arterovenous fistula or central venous catheter
* thrice weekly HD treatment schedule
* Acute hypotensions in the last month before study start \> 20% of sessions