Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05250167
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2022-02-06
Brief Title:
Skeletal Muscle Oxygenation in Patients With Chronic Kidney Disease Stage 2 3 and 4
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
Skeletal Muscle Oxygenation in Patients With Chronic Kidney Disease Stage 2 3 and 4
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 muscles 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
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 inclusionexclusion 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 flowvolume is verified by total hemoglobin The cuff is then rapidly deflated and reoxygenation responses are recorded After a subsequent 10-minute rest the participants 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 SBPDBP are recorded by photo-plethysmography Finometer pro Finapres Medical Systems Amsterdam The Netherlands throughout the protocol
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 flowvolume is verified by total hemoglobin The cuff is then rapidly deflated and reoxygenation responses are recorded After a subsequent 10-minute rest the participants 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 SBPDBP are recorded by photo-plethysmography Finometer pro Finapres Medical Systems Amsterdam The Netherlands throughout the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None