Acute Intradialytic HypotensionSOGLIANCT01759641
Observational Study to Assess Oxygen Saturation Predictive Power Related to Intradialytic Acute Hypotension
An observational study of Acute Intradialytic Hypotension, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Intradialytic Hypotension
- What is being tested?
- Hypotension-prone patients
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ESRD patients on RRT with a recent clinical history of acute intradialytic hypotension.
Who may be able to join
- 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
Who cannot join
- Mental illness
- life expectancy < 6 months
- any profiling and/or biofeedback strategies routinely prescribed
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero-Universitaria "S. Orsola-Malpighi", Nephrology, Dialysis and Hypertension dpt.
Bologna, 40057
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Intradialytic Hypotension
- Being tested
- Hypotension-prone patients
- Keywords
- Dialysis, Monitoring, Cardiovascular stability, biosignals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension-prone patientsDevice
Also called Hemox
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypotension-prone patients | The study group included all patients treated with standard HD prone to acute intradialytic hypotension. Receives: Device: Hypotension-prone patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Intradialytic HypotensionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Santoro, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Antonio Santoro, MD, Principal investigator, Azienda ospedaliera universitaria "S. Orsola-Malpighi", Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759641
- Sponsor's protocol ID
- CRC-MAL 01
- Acronym
- SOGLIA
- Status last verified
- Dec 2012
- First submitted
- 24 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20813866Santoro 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.
PubMed 12164888Gueler 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.
PubMed 15711040
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Group of Study on the Role of Oxygen Saturation as a Potential Surrogate Marker of Intradialytic Cardiovascular Instability
- ClinicalTrials.gov ID
- NCT01759641
- Acronym / sponsor ID
- SOGLIA / CRC-MAL 01
- Conditions
- Acute Intradialytic Hypotension
- Keywords
- Dialysis, Monitoring, Cardiovascular stability, biosignals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypotension-prone patients | – | Device: Hypotension-prone patientsThe study group included all patients treated with standard HD prone to acute intradialytic hypotension. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ESRD patients on RRT with a recent clinical history of acute intradialytic hypotension.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Mental illness
- life expectancy < 6 months
- any profiling and/or biofeedback strategies routinely prescribed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypotension-prone patientsAlso: HemoxHemox 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. | Device | Hypotension-prone patients |
Primary outcome
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)
1 secondary outcome
Central venous catheters subgroup analysis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Background: PubMed 20813866Locatelli 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.
- Background: PubMed 12164888Santoro 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.
- Background: PubMed 15711040Gueler 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Santoro, MD principal investigator
Azienda ospedaliera universitaria "S. Orsola-Malpighi", Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Intradialytic Hypotension, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SO2 short-term variability predictive power (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759641, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.