Clinical Observational Study into Mitochondrial Oxygenation Predicting Ominous Lactate In Trajectory around Abdominal Surgery

Clinical Observational Study into Mitochondrial Oxygenation Predicting Ominous Lactate In Trajectory around Abdominal Surgery - COSMOPOLITAS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49214

Enrollment

Registered

2020-12-15

Start date

2021-03-25

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

hepatectomy large abdominal surgery liver surgery liver transplantation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age over 18 years Acceptable proficiency of the Dutch language Scheduled for major abdominal surgery, the primary focus will be on liver resection and liver transplantation surgery Written informed consent has been signed prior to or on admission to the surgical ward before surgery

Exclusion criteria

Exclusion criteria: Presence of mitochondrial disease Pregnancy/lactation Patients with skin lesions on upper arm/shoulder which impede measurements Porphyria Known intolerance to components of the ALA plaster Patients uncapable of providing informed consent, due to a mental condition interfering with the ability to understand the provided information

Design outcomes

Primary

Measure	Time frame
- MitoPO2 (mmHg) measured semi-continuously peri-operatively and during 48 hours post-operatively using the automated setting of the COMET-device - Arterial lactate levels (mmol/l) measured four times per 24 hours or until available	—

Secondary

Measure	Time frame
- Feasibility and accuracy of COMET measurements in an awake population during a 48 hr post-operative trajectory will be judged based on signal quality of the measurements during this period and the experiences of the researchers and patients - The capability of the 5-ALA patch to provide 5-ALA which will be metabolized into PpIX for the purpose of fluorescence-based measurements will be evaluated by the signal quality of the mitoPO2 measurements after prolonged hours of measurements, defined as over 24 hours of measurements. This can be evaluated without involvement of the patient. - Adverse events will be monitored throughout the study period. Special attention will be attenuated to the plaster site by daily investigation. Subjects will be asked if any physical discomfort has taken place and their overall experience. - Experience of patients regarding the ALA-plasters, COMET Sensor Holder and measurements, collected during a telephone call two weeks after their hospital admission - Laboratory values (hemoglobin mmol/l, ALAT U/l, ASAT U/l and creatinine umol/l) are sampled according to standard care - Urine production and fluid balance during ICU/PACU admission, measured during standard care will be registered - Throughout the operation and the first 24 hours on the ICU, standard hemodynamic parameters, such as blood pressure (mmHg), heart rate (bpm) and oxygen saturation (%) are recorded every minute during the operation and every 15 minutes on the ICU. On the ward they are measured and recorded three times a day. - Clinical outcome, such as length of ICU stay, length of hospital stay - Post-operative complications, especially wound infection and impaired kidney function. Kidney function will be based on serum creatinine and urine production - The effect of time interval on signal quality will be judged based on signal quality of measurements with different time-intervals - Delta temperature (measured non-invasively, using core temper	—

Measure

Time frame

- Feasibility and accuracy of COMET measurements in an awake population during a 48 hr post-operative trajectory will be judged based on signal quality of the measurements during this period and the experiences of the researchers and patients - The capability of the 5-ALA patch to provide 5-ALA which will be metabolized into PpIX for the purpose of fluorescence-based measurements will be evaluated by the signal quality of the mitoPO2 measurements after prolonged hours of measurements, defined as over 24 hours of measurements. This can be evaluated without involvement of the patient. - Adverse events will be monitored throughout the study period. Special attention will be attenuated to the plaster site by daily investigation. Subjects will be asked if any physical discomfort has taken place and their overall experience. - Experience of patients regarding the ALA-plasters, COMET Sensor Holder and measurements, collected during a telephone call two weeks after their hospital admission - Laboratory values (hemoglobin mmol/l, ALAT U/l, ASAT U/l and creatinine umol/l) are sampled according to standard care - Urine production and fluid balance during ICU/PACU admission, measured during standard care will be registered - Throughout the operation and the first 24 hours on the ICU, standard hemodynamic parameters, such as blood pressure (mmHg), heart rate (bpm) and oxygen saturation (%) are recorded every minute during the operation and every 15 minutes on the ICU. On the ward they are measured and recorded three times a day. - Clinical outcome, such as length of ICU stay, length of hospital stay - Post-operative complications, especially wound infection and impaired kidney function. Kidney function will be based on serum creatinine and urine production - The effect of time interval on signal quality will be judged based on signal quality of measurements with different time-intervals - Delta temperature (measured non-invasively, using core temper

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Countries

Netherlands

Outcome results