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Chronic Kidney DiseasesNCT05250167

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

An observational study of Chronic Kidney Diseases, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Endothelial dysfunction occurs early in chronic kidney disease (CKD) and is associated with target organ damage, progression of renal injury, cardiovascular events, and mortality. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Kidney Diseases
How many people
90 participants
Where
1 siteGreece
Study dates
1 Jun 2021to 30 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Active malignant disease or other comorbidity with poor prognosis
  • Active infection or relevant inter-current illness
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Department of Nephrology, Hippokration Hospital

    Thessaloniki, 54642

Other trials in Greece

About this study

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.

Read the detailed description

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.

Keywords
chronic kidney disease, NIRS, muscle oxygenation, cerebral oxygenation, microvascular function
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05250167
Study groupRoleWhat they receive
CKD patients stage 2Not described
CKD patients stage 3aNot described
CKD patients stage 3bNot described
CKD patients stage 4Not described
Controls without CKDNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in skeletal muscle oxygen saturation (TSI%) at rest.

    Measured: Baseline

Secondary outcomes (20)
  1. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI slope during occlusion

    Measured: Baseline

  2. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI magnitude during occlusion

    Measured: Baseline

  3. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle oxygen consumption during occlusion

    Measured: Baseline

  4. 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)

    Measured: Baseline

  5. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI slope during reperfusion

    Measured: Baseline

  6. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in muscle TSI magnitude during reperfusion

    Measured: Baseline

  7. 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)

    Measured: Baseline

  8. 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)

    Measured: Baseline

  9. 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)

    Measured: Baseline

  10. 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)

    Measured: Baseline

  11. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in cerebral oxygenation at rest (TSI)

    Measured: Baseline

  12. 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)

    Measured: Baseline

  13. 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)

    Measured: Baseline

  14. 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)

    Measured: Baseline

  15. 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)

    Measured: Baseline

  16. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office pulse wave velocity.

    Measured: Baseline

  17. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office augmentation pressure and augmentation index.

    Measured: Baseline

  18. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office central systolic and diastolic blood pressure

    Measured: Baseline

  19. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in office brachial systolic and diastolic blood pressure

    Measured: Baseline

  20. Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in carotid intima-media thickness

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2022
  2. Study start1 Jun 2021
  3. Primary completion30 May 2022
  4. Study completion30 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05250167
Sponsor's protocol ID
ΔΔ4871
Status last verified
Jul 2022
First submitted
6 Feb 2022
Last updated
21 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Theodorakopoulou MP, Schoina M, Sarafidis P. Assessment of Endothelial and Microvascular Function in CKD: Older and Newer Techniques, Associated Risk Factors, and Relations with Outcomes. Am J Nephrol. 2020;51(12):931-949. doi: 10.1159/000512263. Epub 2020 Dec 11.

    PubMed 33311014
  • Dipla K, Triantafyllou A, Koletsos N, Papadopoulos S, Sachpekidis V, Vrabas IS, Gkaliagkousi E, Zafeiridis A, Douma S. Impaired Muscle Oxygenation and Elevated Exercise Blood Pressure in Hypertensive Patients: Links With Vascular Stiffness. Hypertension. 2017 Aug;70(2):444-451. doi: 10.1161/HYPERTENSIONAHA.117.09558. Epub 2017 Jun 12.

    PubMed 28607132
  • Moody WE, Edwards NC, Madhani M, Chue CD, Steeds RP, Ferro CJ, Townend JN. Endothelial dysfunction and cardiovascular disease in early-stage chronic kidney disease: cause or association? Atherosclerosis. 2012 Jul;223(1):86-94. doi: 10.1016/j.atherosclerosis.2012.01.043. Epub 2012 Feb 2.

    PubMed 22349087
  • Kintiraki E, Dipla K, Triantafyllou A, Koletsos N, Grigoriadou I, Poulakos P, Sachpekidis V, Vrabas IS, Zafeiridis A, Bili E, Douma S, Goulis DG. Blunted cerebral oxygenation during exercise in women with gestational diabetes mellitus: associations with macrovascular function and cardiovascular risk factors. Metabolism. 2018 Jun;83:25-30. doi: 10.1016/j.metabol.2018.01.009. Epub 2018 Feb 2.

    PubMed 29410188

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Diseases, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences between CKD stages (stage 2, 3a, 3b and 4) and controls in skeletal muscle oxygen saturation (TSI%) at rest. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05250167, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.

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