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Study to assess the accuracy of two continuous glucose monitors in relation to the microcirculatory function at the adult intensive care.

Tissue oxygenation and perfusion and the determination of glucose subcutaneously.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23067
Enrollment
60
Registered
2009-04-29
Start date
2009-06-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

continuous glucose monitoring (continue glucose monitoring) microcirculation (microcirculatie) intensive care unit (intensive care) cardiothoracic surgery (cardiothoracale chirurgie)

Interventions

None listed

Sponsors

P.H.J. van der Voort, MD, PhD Onze Lieve Vrouwen Gasthuis Oosterpark 9, 1091 AC Amsterdam, the Netherlands Email: p.h.j.vandervoort@olvg.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Admission to the hospital for elective open cardiac surgery (coronaty artery bypass graftl mitral-, tricuspidal- and aortic valve surgery); 2. Age 18-85 years; 3. Willing and able to give written informed consent.

Exclusion criteria

Exclusion criteria: Abdominal abnormalities that inhibit sensor insertion.

Design outcomes

Primary

MeasureTime frame
Difference in glucose values (mmol/l) measured by the two CGMs, Guardian RT and FreeStyle Navigator, compared to 'gold standard' blood glucose values measured by the Accu-Chek Compact Plus (mmol/l), expressed as mean absolute difference (MAD) of glucose values.

Secondary

MeasureTime frame
1. Microcirculatory function expressed as % of perfused vessels as measured by OPS; 2. Microcirculatory function expressed as microvascular flow index (MFI) as measured by OPS; 3. Tissue oxygen saturation (StO2) expressed as ratio oxygenated haemoglobin to total haemoglobin as measured by near infrared spectroscopy (NIRS); 4. Systemic oxygen saturation (SpO2) expressed as % as measured by pulse oximetry; 5. APACHE II score; 6. SOFA score.

Contacts

Public ContactS.E. Siegelaar
s.e.siegelaar@amc.uva.nl+31 (0)20 5665981

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)