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

Italian Group of Study on the Role of Oxygen Saturation as a Potential Surrogate Marker of Intradialytic Cardiovascular Instability

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01759641
Acronym
SOGLIA
Enrollment
51
Registered
2013-01-03
Start date
2011-01-31
Completion date
2012-08-31
Last updated
2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Intradialytic Hypotension

Keywords

Dialysis, Monitoring, Cardiovascular stability, biosignals

Brief summary

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.

Detailed description

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.

Interventions

DEVICEHypotension-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.

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Exclusion criteria

* Mental illness * life expectancy \< 6 months * any profiling and/or biofeedback strategies routinely prescribed

Design outcomes

Primary

MeasureTime frameDescription
SO2 short-term variability predictive power3 monthsSO2 short term variability predictive power was assessed by means of common clinical tests indexes: sensitivity (number of sessions with effective hypotension correctly classified using SO2 standard deviation analysis) specificity (number of sessions without hypotension correctly classified using SO2 standard deviation analysis)

Secondary

MeasureTime frameDescription
Central venous catheters subgroup analysis3 monthsThis analysis was performed, according to the method described in the Primary Outcome section, only on the group of sessions in which a central catheter was used as vascular access.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026