Observational Study to Assess Oxygen Saturation Predictive Power Related to Intradialytic Acute Hypotension (SOGLIA)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Intradialytic Hypotension |
Device: Hypotension-prone patients |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Italian Group of Study on the Role of Oxygen Saturation as a Potential Surrogate Marker of Intradialytic Cardiovascular Instability |
- SO2 short-term variability predictive power [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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)
- Central venous catheters subgroup analysis [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
| Enrollment: | 51 |
| Study Start Date: | January 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 Name: Hemox
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
ESRD patients on RRT with a recent clinical history of acute intradialytic hypotension.
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
Contacts and Locations| Italy | |
| Azienda Ospedaliero-Universitaria "S. Orsola-Malpighi", Nephrology, Dialysis and Hypertension dpt. | |
| Bologna, Italy, 40057 | |
| Principal Investigator: | Antonio Santoro, MD | Azienda ospedaliera universitaria "S. Orsola-Malpighi", Bologna, Italy |
More Information
Publications:
| Responsible Party: | Antonio Santoro, Professor Antonio Santoro MD, Chief of Nephrology, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
| ClinicalTrials.gov Identifier: | NCT01759641 History of Changes |
| Other Study ID Numbers: | CRC-MAL 01 |
| Study First Received: | December 24, 2012 |
| Last Updated: | December 24, 2012 |
| Health Authority: | Italy: National Institute of Health |
Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
|
Dialysis Monitoring Cardiovascular stability biosignals |
Additional relevant MeSH terms:
|
Hypotension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013