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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Santoro, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01759641
First received: December 24, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • 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)



Secondary Outcome Measures:
  • 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759641

Locations
Italy
Azienda Ospedaliero-Universitaria "S. Orsola-Malpighi", Nephrology, Dialysis and Hypertension dpt.
Bologna, Italy, 40057
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014