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Skeletal Muscle Oxygenation in Patients With Chronic Kidney Disease Stage 2, 3 and 4

20. července 2022 aktualizováno: Marieta Theodorakopoulou, Aristotle University Of Thessaloniki
Endothelial dysfunction occurs early in chronic kidney disease (CKD) and is associated with target organ damage, progression of renal injury, cardiovascular events, and mortality. Near-infrared spectroscopy (NIRS) is a relevant new, noninvasive method that assesses local tissue oxygenation and can provide valuable information about local oxygen consumption and blood flow. Using postocclusion reactive hyperemia, NIRS technology provides valuable information on skeletal muscle's oxidative capacity, microvascular function, and muscle oxygenation at rest and during exercise. With regard to cerebral oxygenation, NIRS noninvasively monitors alterations and assesses relative changes from baseline for oxygenated, deoxygenated, and total hemoglobin. Due to its ability to assess microvascular function, NIRS has been applied in various populations with impaired microvascular function, including patients with hypertension, diabetes, CAD, and end-stage kidney disease. However, there is no study up to date assessing muscle oxygenation and microvascular function measured via NIRS in patients with different stages of CKD. Hence, this study aims to examine possible differences in muscle and oxygenation at rest, exercise, and during an occlusion-reperfusion maneuver in CKD stages 2-4 with NIRS. In addition, this is the first study examining potential associations between micro-, macrovascular dysfunction and potentially impaired muscle and cerebral oxygenation in CKD patients.

Přehled studie

Postavení

Dokončeno

Detailní popis

This is a cross-sectional study performed in the Department of Nephrology, Hippokration Hospital, Thessaloniki, Greece. For the purposes of this study, consecutive CKD patients stage 2-4 regularly followed in outpatient clinics of the Department of Nephrology, and fulfilling the inclusion/exclusion criteria, as well as controls without CKD, were invited to participate. All included patients signed a written informed consent form. The study protocol was approved by the Ethics Committee of the School of Medicine, Aristotle University of Thessaloniki. All procedures and evaluations are performed according to the Declaration of Helsinki 2013 Amendment.

Baseline evaluation includes the recording of demographics, anthropometric characteristics, CKD cause, comorbidities, concomitant medications, and a detailed physical examination. The Mini-Mental State Exam (MMSE) is used for the assessment of cognitive function; physical activity status is evaluated by the International Physical Activity Questionnaire. Study participants are advised to refrain from food, caffeine, alcohol, or tobacco for 12 h and received any standard medication before their morning appointment in the research laboratory to perform the assessments described below. BP measurements are performed thrice after 10 min of rest, in the sitting position, at the level of the brachial artery, with a validated oscillometric device [Omron M3 Intellisense (Omron Healthcare, Kyoto, Japan)] and a cuff of appropriate size, according to current guidelines. Afterwards, venous blood samples are collected for routine laboratory parameters. Office arterial stiffness and arterial wave parameters are measured with applanation tonometry using the Sphygmocor device (AtCor, Sydney, Australia). The common carotid intima-media thickness (cIMT) is measured with a 2D ultrasound device (GE Healthcare Ultrasound, Vivid S5, 8L-RS probe, USA) in the CCA between the middle and inner surface of the right and left artery wall, which is represented by a dense double-line pattern. Next, the participant is connected to the experimental apparatus for assessment of muscle and cerebral oxygenation via NIRS (Artinis, The Netherlands). The NIRS device is placed: a) on the forearm of the dominant limb for non-invasive monitoring of skeletal muscle oxygenation (absolute values and relative changes from baseline for oxygenated, deoxygenated, and total hemoglobin as well as tissue saturation index (TSI), as an absolute parameter for muscle oxygenation), and b) over the prefrontal cortex (contra-laterally of the dominant arm), 2 cm beside the midline and about 3 cm above the supraorbital ridge for assessing cerebral oxygenation. In brief, after calibration, with the participant in the seated position, baseline values are obtained, and a 5-minute arterial occlusion is performed. The cuff is rapidly inflated to suprasystolic levels (ie, 250 mm Hg), to obstruct blood flow to forearm muscles and measure the maximal capacity for oxygen extraction by skeletal muscles. Stable blood flow/volume is verified by total hemoglobin. The cuff is then rapidly deflated, and reoxygenation responses are recorded. After a subsequent 10-minute rest, the participant's maximal voluntary contraction (MVC) is assessed, using a digital dynamometer (K-Force, K-invent), followed by a 3-minute submaximal handgrip exercise test (set of 30 s exercise at 35% MVC with 3 s rest). The participant has visual feedback to maintain the force output to the predetermined MVC percentage. At the completion of the exercise protocol, the Rate of Perceived Exertion (RPE) is assessed using the the Borg scale. Continuous beat-by-beat SBP/DBP are recorded by photo-plethysmography (Finometer pro, Finapres Medical Systems, Amsterdam, The Netherlands) throughout the protocol.

Typ studie

Pozorovací

Zápis (Aktuální)

90

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Thessaloniki, Řecko, 54642
        • Department of Nephrology, Hippokration Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

This study includes patients with CKD stage 2, 3a, 3b and 4 (CKD-EPI eGFR: <90 και ≥30mL/min/1.73m2) and controls without CKD.

Popis

Inclusion Criteria:

  • Age>18 years
  • Patients with CKD stage 2, 3a, 3b, 4 (CKD-EPI eGFR: <90 and ≥30mL / min / 1.73m2) and controls without CKD
  • Provision of informed written signed consent prior to study entry

Exclusion Criteria:

  • Kidney transplant recipients
  • Myocardial infarction or unstable angina episode within the past 3 months, or congestive heart failure class III-IV according to New York Heart Association criteria
  • Patients with history of stroke, dementia or other severe neurologic disorders (e.g. Parkinson's disease, multiple sclerosis, etc)
  • Patients with severe mental disorders
  • History of drug or alcohol abuse
  • Patients with muscle disorders
  • Active malignant disease or other comorbidity with poor prognosis
  • Active infection or relevant inter-current illness
  • Pregnancy

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
CKD patients stage 2
CKD patients stage 3a
CKD patients stage 3b
CKD patients stage 4
Controls without CKD

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in skeletal muscle oxygen saturation (TSI%) at rest.
Časové okno: Baseline
Baseline

Sekundární výstupní opatření

Měření výsledku
Časové okno
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI slope during occlusion
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI magnitude during occlusion
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle oxygen consumption during occlusion
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in the hyperemia range (calculated as the difference between maximal TSI during reperfusion and rest TSI)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI slope during reperfusion
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI magnitude during reperfusion
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle oxygenation during a 3-min handgrip exercise (35% of maximal voluntary capacity) (TSI change from baseline)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle oxygenation during a 3-min handgrip exercise (35% of maximal voluntary capacity) (O2Hb change from baseline)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle oxygenation during a 3-min handgrip exercise (35% of maximal voluntary capacity) (HHb change from baseline)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle total blood volume during a 3-min handgrip exercise (35% of maximal voluntary capacity) (tHb change from baseline)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in cerebral oxygenation at rest (TSI)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in cerebral oxygenation during a 3-min handgrip exercise (35% of maximal voluntary capacity) (TSI change from baseline)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in cerebral oxygenation during a 3-min handgrip exercise (35% of maximal voluntary capacity) (O2Hb change from baseline)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in cerebral oxygenation during a 3-min handgrip exercise (35% of maximal voluntary capacity) (HHb change from baseline)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in cerebral total blood volume during a 3-min handgrip exercise (35% of maximal voluntary capacity) (tHb change from baseline)
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office pulse wave velocity.
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office augmentation pressure and augmentation index.
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office central systolic and diastolic blood pressure
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office brachial systolic and diastolic blood pressure
Časové okno: Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in carotid intima-media thickness
Časové okno: Baseline
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. června 2021

Primární dokončení (Aktuální)

30. května 2022

Dokončení studie (Aktuální)

30. května 2022

Termíny zápisu do studia

První předloženo

6. února 2022

První předloženo, které splnilo kritéria kontroly kvality

17. února 2022

První zveřejněno (Aktuální)

22. února 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. července 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. července 2022

Naposledy ověřeno

1. července 2022

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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