Observational Study to Assess Oxygen Saturation Predictive Power Related to Intradialytic Acute Hypotension (SOGLIA)
|ClinicalTrials.gov Identifier: NCT01759641|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : January 3, 2013
|Condition or disease||Intervention/treatment|
|Acute Intradialytic Hypotension||Device: Hypotension-prone patients|
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 .
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 .
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 . 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|
|Actual Enrollment :||51 participants|
|Official Title:||Italian Group of Study on the Role of Oxygen Saturation as a Potential Surrogate Marker of Intradialytic Cardiovascular Instability|
|Study Start Date :||January 2011|
|Primary Completion Date :||September 2011|
|Study Completion Date :||August 2012|
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
- SO2 short-term variability predictive power [ Time Frame: 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)
- Central venous catheters subgroup analysis [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759641
|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|