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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030432
Receipt No. R000034745
Scientific Title The effect of the blood concentrations of asymmetric dimethylarginine and arginine on the cerebrovascular CO2 reactivity during general anesthesia in the patients with chronic renal failure
Date of disclosure of the study information 2017/12/17
Last modified on 2019/06/23

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Basic information
Public title The effect of the blood concentrations of asymmetric dimethylarginine and arginine on the cerebrovascular CO2 reactivity during general anesthesia in the patients with chronic renal failure
Acronym Cerebrovascular CO2 reactivity during general anesthesia in patients with chronic renal failure
Scientific Title The effect of the blood concentrations of asymmetric dimethylarginine and arginine on the cerebrovascular CO2 reactivity during general anesthesia in the patients with chronic renal failure
Scientific Title:Acronym Cerebrovascular CO2 reactivity during general anesthesia in patients with chronic renal failure
Region
Japan

Condition
Condition In principal, chronic renal failure patients (creatinine concentration equal or more than 4mg) for planning living-related renal transplantation patients under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the cerebrovascular reactivity to CO2(CO2R) partial pressure in the chronic renal failure patients under general anesthesia.
Basic objectives2 Others
Basic objectives -Others To examine the effect of blood concentration of BUN, creatinine, asymmetric dimethylargininase (ADMA), L-Arginine and L-Arginine/ADMA ratio on CO2R in the chronic renal failure patients.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The comparison of CO2R between the chronic renal failure patients and patients without it during general anesthesia.
Key secondary outcomes Evaluation of the effect of blood concentration of BUN, creatinine, asymmetric dimethylargininase (ADMA), L-Arginine and L-Arginine/ADMA ratio on CO2R in the chronic renal failure patients.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Chronic renal failure cases caused by glomerulonephritis.
2. Cases whose blood creatinine concentrations are equal or more than 4mg/dL.
3. Cases who are undergoing renal plantation, arteriovenous shunt formation for hemodialysis and catheter implantation for continuous ambulatory peritoneal dialysis under general anesthesia.
4. Cases with controlled hypertension along with who criteria.
5. Control cases with American society of anesthesiologist physical status 1.
6. Control cases with estimated glomerular filtration rate equal or more than 60 ml/min/1.73m2.
7. Control cases who are undergoing nephrectomy or general surgery under general anesthesia.
Key exclusion criteria 1. Cases whose hemoglobin concentrations are below 8g/dL.
2. Cases who cannot measure the blood flow velocity in middle cerebral artery by transcranial Doppler.
3. Laparoscopic surgery cases.
4. Emergency cases.
5. Cases with pregnancy.
6. Cases with uncontrolled hypertension.
7. Cases with atrial fibrillation, paroxysmal atrial fibrillation and premature ventricular contraction more than 10 times per minute.
8. History of cerebrovascular disease.
9. History of angina pectoris.
10. Chronic renal failure caused by diabetes mellitus, hypertension, gout, liver disease, drug induced and pregnancy.
11. Control cases with estimated glomerular filtration rate below 60 ml/min/1.73m2.
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Kazuyoshi
Middle name
Last name Ishida
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code 7558505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2291
Email ishid002@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Kazuyoshi
Middle name
Last name Ishida
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code 7558505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2291
Homepage URL
Email ishid002@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yamaguchi University hospital IRB center
Address 1-1-1 Minamikogushi,Ube,Yamaguchi, Japan
Tel 0836-22-2428
Email me223@yamaguchi-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 17 Day

Related information
URL releasing protocol https://nsas.anesth.or.jp/App/Datura/sm/63/session/P2-27.html#P2-27-2
Publication of results Partially published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s00540-017-2422-3
Number of participants that the trial has enrolled 75
Results
We examined cerebrovascular CO2 reactivity(CO2R) in chronic renal failure(CRF) patients(n 62) under general anesthesia,comparing those with the patients without CRF (controls n 13).Despite no significant differences in the absoluteand relative values of CO2R between the CRF and control groups,blood urea nitrogen(BUN) concentrations in the CRF group correlated inversely with both absolute and relative CO2R.L arginine concentrations in the CRF group correlated inversely with relative CO2R(n 16).

Results date posted
2019 Year 06 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2017 Year 11 Month 04 Day
Baseline Characteristics
All patients in the CRF group had glomerulonephritis,blood creatinine concentration more than 4mg dl-1 with controlled blood pressure and hemoglobin concentration more than 8g dl-1,and were scheduled for living related renal transplantation.The 13 patients in the control group were classed as American Society of Anesthesiologists(ASA) physical status(PS)1.
Participant flow
Patients with DM, uncontrolled hypertension,
peripheral vascular disease, or neurological disease including cerebral vascular disease, as well as those with a Hb concentration < 8 g/dl were excluded from the study.
Adverse events
none
Outcome measures
Evaluation of the absolute CO2R and reelative CO2R.Association between the CO2R and blood concentration of BUN,asymmetric dimethylarginine and L-arginine
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 03 Month 28 Day
Date of IRB
2004 Year 08 Month 18 Day
Anticipated trial start date
2017 Year 12 Month 17 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 09 Month 22 Day
Date trial data considered complete
2018 Year 09 Month 22 Day
Date analysis concluded
2018 Year 12 Month 01 Day

Other
Other related information This study is planning for evaluating the cerebrovascular reactivity to CO2 partial pressure by transcranial Doppler ultrasonography in chronic renal failure cases and compare it with control patients without renal failure.The association between the humoral factors such as BUN,creatinine asymmetric dimethylarginine and L arginine concentrations and CO2 cerebrovascular reactivity will be evaluated.Our institutional Medicine Ethics Committee for Human Study judged that the present study was observational prospective study.Thus,the start of the preset study was August 2004.UMIN ICDR registration for the present study was applied after starting the study.

Management information
Registered date
2017 Year 12 Month 17 Day
Last modified on
2019 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034745

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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