UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030432
Receipt number 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 20:16:33

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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 or person

Institute

Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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