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

Completed

• Conditions: Acute Intradialytic Hypotension
• Interventions: Device: Hypotension-prone patients

• Registration Number: NCT01759641
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-09
• Study Completion: 2012-08
• Status Verified: 2012-12
• Study First Submitted: 2012-12-24
• Study First Submitted QC: 2012-12-24
• Last Update Submitted: 2012-12-24
• Study First Posted: 2013-01-03
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypotension-prone patients	Hypotension-prone patients	The study group included all patients treated with standard HD prone to acute intradialytic hypotension.

Primary Outcome Measures

Name	Time	Method
SO2 short-term variability predictive power	3 months	SO2 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 Outcome Measures

Name	Time	Method
Central venous catheters subgroup analysis	3 months	This 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.

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria "S. Orsola-Malpighi", Nephrology, Dialysis and Hypertension dpt.; 🇮🇹 Bologna, Italy