UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007860 |
|---|---|
| Receipt number | 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 16:22:26 |
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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
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
masuika@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009262
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
