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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Intradialytic Hypotension
• Intervention / Treatment: Device: Hypotension-prone patients

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40057
    • Azienda Ospedaliero-Universitaria "S. Orsola-Malpighi", Nephrology, Dialysis and Hypertension dpt.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ESRD patients on RRT with a recent clinical history of acute intradialytic hypotension.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypotension-prone patients; The study group included all patients treated with standard HD prone to acute intradialytic hypotension.	Device: 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.; Other Names: Hemox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SO2 short-term variability predictive power	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)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central venous catheters subgroup analysis	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.	3 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Antonio Santoro, MD, Azienda ospedaliera universitaria "S. Orsola-Malpighi", Bologna, Italy

Publications and helpful links

General Publications

• Santoro A, Mancini E, Basile C, Amoroso L, Di Giulio S, Usberti M, Colasanti G, Verzetti G, Rocco A, Imbasciati E, Panzetta G, Bolzani R, Grandi F, Polacchini M. Blood volume controlled hemodialysis in hypotension-prone patients: a randomized, multicenter controlled trial. Kidney Int. 2002 Sep;62(3):1034-45. doi: 10.1046/j.1523-1755.2002.00511.x.
• Locatelli F, Altieri P, Andrulli S, Bolasco P, Sau G, Pedrini LA, Basile C, David S, Feriani M, Montagna G, Di Iorio BR, Memoli B, Cravero R, Battaglia G, Zoccali C. Hemofiltration and hemodiafiltration reduce intradialytic hypotension in ESRD. J Am Soc Nephrol. 2010 Oct;21(10):1798-807. doi: 10.1681/ASN.2010030280. Epub 2010 Sep 2.
• Gueler F, Gwinner W, Schiborr C, Martin M, Klos A, Kirsch T, Fiebeler A, Haller H, Fliser D. Biocompatibility parameters of different dialysis membranes assessed during systemic inflammation. Blood Purif. 2005;23(3):196-202. doi: 10.1159/000083941. Epub 2005 Feb 10.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: December 24, 2012
• First Submitted That Met QC Criteria: December 24, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Estimate): January 3, 2013
• Last Update Submitted That Met QC Criteria: December 24, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Monitoring; Dialysis; biosignals; Cardiovascular stability
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: CRC-MAL 01