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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001907
Receipt No. R000002318
Scientific Title Assessment of gastroesophageal reflex disease (GERD) with FSSG score in hemodialysis patients
Date of disclosure of the study information 2009/04/25
Last modified on 2010/12/04

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Basic information
Public title Assessment of gastroesophageal reflex disease (GERD) with FSSG score in hemodialysis patients
Acronym Frequency Invistigation of GERD in Hemodialysis Therapy: FIGHT
Scientific Title Assessment of gastroesophageal reflex disease (GERD) with FSSG score in hemodialysis patients
Scientific Title:Acronym Frequency Invistigation of GERD in Hemodialysis Therapy: FIGHT
Region
Japan

Condition
Condition Gastroesophageal reflux disease (GERD)
Chronic hemodialysis patients
Classification by specialty
Gastroenterology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study 1) The first aim of this study is to assess the scores of FSSG in hemodialysis patients.
Study 2) The second aim is to assess the improvement of FSSG scores and GIF findings after PPI treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Study 1) FSSG (Frequency scale for the symptom of GERD) scores and findings of gastrointestinal fiber (GIF).
Study 2) Reduction in FSSG scores.
Key secondary outcomes Association between concomitant drugs and FSSG scores.

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
80 years-old >
Gender Male and Female
Key inclusion criteria Chronic hemodialysis patients
Key exclusion criteria 1) Patients with malignancy whose prognoses are predicted less than 6 months.
2) Patients with severe heart failure or hepatic failure.
3) Patients who have epigastric symptoms other than GERD.
4) Patients who have histories of renal transplantation.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Enyu Imai
Organization Osaka University Graduate School of Medicine
Division name Nephrology
Zip code
Address Box: B6, 2-2, Yamadaoka, Suita-city, Osaka, Japan
TEL 06-6879-3857
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuyuki Nagasawa
Organization Osaka University Graduate School of Medicine
Division name Nephrology
Zip code
Address Box: B6, 2-2, Yamadaoka, Suita-city, Osaka, Japan
TEL 06-6879-3857
Homepage URL
Email nagasawa@kid.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization Grants-in-aid for scientific research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tanaka-Kitanoda Hospital, Akagaki Clinic, Imai Clinic, Kajimoto Clinic
Name of secondary funder(s) None

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
2009 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results
Their average age was 66 years (58-73), with average hemodialysis duration of 5 years. A positive FSSG result (score>=8) was recorded by 21 patients out of 167 subjects, indicating the existence of GERD, despite almost 80% of subjects already on Proton pump inhibitors, Histamine receptor 2 antagonists and/or Gastromucosal protective agent (GMP). To avoid the effect of advanced age upon gastroesophageal symptoms, we analyzed 112 hemodialysis patients under 70 years old. The average age was 62 years (56-66), with average hemodialysis duration of 7 years. 11.6% of hemodialysis patients under 70 yielded positive FSSG results (score>8). GMP use negatively correlated with the dysmotility score (p=0.013). Multivariate logistic regression analysis also confirmed that calcium channel blocker use, common in dialysis patients, correlated with the acid reflux score (p=0.042). No correlation was seen between endoscopic findings and FSSG scores. 

Conclusion
12.5% of hemodialysis patients yielded positive FSSG results (score>8), indicating the presence of GERD. The FSSG shows promise as a useful tool in the diagnosis of GERD in hemodialysis patients.
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 Completed
Date of protocol fixation
2008 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information In general population, those who have higher FSSG score than 8 account 17%. However, there is no report on dialysis patients.

Management information
Registered date
2009 Year 04 Month 25 Day
Last modified on
2010 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002318

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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