このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2022年7月20日 更新者: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.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

観察的

入学 (実際)

90

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Thessaloniki、ギリシャ、54642
        • Department of Nephrology, Hippokration Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
CKD patients stage 2
CKD patients stage 3a
CKD patients stage 3b
CKD patients stage 4
Controls without CKD

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in skeletal muscle oxygen saturation (TSI%) at rest.
時間枠:Baseline
Baseline

二次結果の測定

結果測定
時間枠
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI slope during occlusion
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI magnitude during occlusion
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle oxygen consumption during occlusion
時間枠: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)
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI slope during reperfusion
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI magnitude during reperfusion
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in cerebral oxygenation at rest (TSI)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office pulse wave velocity.
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office augmentation pressure and augmentation index.
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office central systolic and diastolic blood pressure
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office brachial systolic and diastolic blood pressure
時間枠:Baseline
Baseline
Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in carotid intima-media thickness
時間枠:Baseline
Baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年6月1日

一次修了 (実際)

2022年5月30日

研究の完了 (実際)

2022年5月30日

試験登録日

最初に提出

2022年2月6日

QC基準を満たした最初の提出物

2022年2月17日

最初の投稿 (実際)

2022年2月22日

学習記録の更新

投稿された最後の更新 (実際)

2022年7月21日

QC基準を満たした最後の更新が送信されました

2022年7月20日

最終確認日

2022年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • ΔΔ4871

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

3
購読する