UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001907 |
|---|---|
| Receipt number | 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 13:41:45 |
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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
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
nagasawa@kid.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002318
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