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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007860
Receipt No. R000009262
Scientific Title the effect of different crystalloid solutions during surgery on body fluid and metabolism in hemodialysis patients
Date of disclosure of the study information 2012/05/01
Last modified on 2012/04/29

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Basic information
Public title the effect of different crystalloid solutions during surgery on body fluid and metabolism in hemodialysis patients
Acronym crystalloid solutions for hemodialysis patients during surgery
Scientific Title the effect of different crystalloid solutions during surgery on body fluid and metabolism in hemodialysis patients
Scientific Title:Acronym crystalloid solutions for hemodialysis patients during surgery
Region
Japan

Condition
Condition chronic renal failure
Classification by specialty
Medicine in general Nephrology Surgery in general
Anesthesiology Laboratory medicine Operative medicine
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Previous studies have shown that metabolic acidosis is a complication of normal saline infusion because
of its high chloride content. Wheares Ringer's lactate contains potassium and can potentially aggravate hyperkalemia in patients with impaired renal function. It remains unclear which is better normal saline or Ringer's acetate during surgery. For this reason, we designed a study comparing metabolic profile and electrolyte in hemodialysis patients managed with saline or Ringer's acetate.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The goal of this study was to determine which is better normal saline or Ringer's solution for serum pottacium level during surgery.
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria adult patients with chronic renal failure on hemodialysis.
Key exclusion criteria serum pottacium level is over 5.5 mmol/L immediately before surgery
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Saito
Organization Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Division name Department of anesthesiology
Zip code
Address 5 Zaifu-cho, Hirosaki 036-8562, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Division name Department of anesthesiology
Zip code
Address
TEL
Homepage URL
Email masuika@cc.hirosaki-u.ac.jp

Sponsor
Institute Department of anesthesiology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2012 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Before induction of anesthesia, an 22-G arterial artery cannula is inserted under local anesthesia. Arterial blood samples were sent for analysis (before
induction of anesthesia, throughout the anesthesia at 60-min intervals, and at the end of operation) for measurement of pH, arterial carbon dioxide tension (PaCO2), serum sodium, potassium,
chloride, and lactate. Additionally serum
bicarbonate concentration and base excess were determined with a blood gas analyzer. At the end of surgery, study fluid was discontinued and all the patients admit to the ICU.

Management information
Registered date
2012 Year 04 Month 29 Day
Last modified on
2012 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009262

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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