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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Bologna, Italië, 40057
- Azienda Ospedaliero-Universitaria "S. Orsola-Malpighi", Nephrology, Dialysis and Hypertension dpt.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Hypotension-prone patients
The study group included all patients treated with standard HD prone to acute intradialytic hypotension.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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SO2 short-term variability predictive power
Tijdsspanne: 3 months
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Central venous catheters subgroup analysis
Tijdsspanne: 3 months
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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.
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3 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Antonio Santoro, MD, Azienda ospedaliera universitaria "S. Orsola-Malpighi", Bologna, Italy
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CRC-MAL 01
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