Decreased salivary flow rate as a dipsogenic factor in haemodialysis patients: a pilocarpine clinical trial
| ISRCTN | ISRCTN41671411 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41671411 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/03/2005
- Registration date
- 19/04/2005
- Last edited
- 15/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Junne-Ming Sung
Scientific
Scientific
138 Shing-Li Road
Tainan
70428
Taiwan
| Phone | +886 6 2353535 ext.2591 |
|---|---|
| jmsung@mail.ncku.edu.tw |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | We conducted a 3-month prospective observational study followed by a trial of pilocarpine - a parasympathomimetic agent shown to effectively increase salivary flow in radiation-induced xerostomia or Sjögren syndrome (27 - 30) - to determine whether the reduction of salivary flow contributes to exaggerated thirst and excess interdialytic weight gain (IDWG) in haemodialysis (HD) patients, and whether pilocarpine can alleviate it. |
| Ethics approval(s) | The study protocol was approved by ethics committees of National Cheng Kung University Hospital and Kuos General Hospital, Tainan, Taiwan, and adhered to the Declaration of Helsinki. |
| Health condition(s) or problem(s) studied | Haemodialysis (HD) patient with large weight gain (>2%/day) |
| Intervention | 5 mg pilocarpine OPD solution (1% pilocarpine HCl ophthalmic solution, Shionogi & Co., Taipei, Taiwan) was used. The placebo was constructed using normal saline and Mill-Q water with 3:7 mixing. The sodium concentration of the two solutions was identical, with both administered in fixed doses (10 drops four times/day, 30 minutes before each meal and at bed time). Ten drops of pilocarpine is equivalent to 5 mg. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pilocarpine |
| Primary outcome measure | The primary outcomes were: 1. Changes in the visual analogue scale (VAS) scores of xerostomia, thirst, and stress of fluid restriction 2. Unstimulated salivary flow rate (UWS) 3. Mean IDWG2days and IDWG3days in each intervention period |
| Secondary outcome measures | The secondary outcomes were: 1. Changes in mean blood pressure 2. Adverse events 3. Blood test results |
| Overall study start date | 01/03/2003 |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | In the observational study, we collected prospective data for 3 consecutive months (December 2002 to February 2003) from 90 participants recruited from a pool of 217 patients undergoing HD at the outpatient dialysis unit of the Kuo's General Hospital. Inclusion criteria included: 1. Maintenance HD three times weekly for at least 6 months 2. Over 18 years of age 3. Daily urine output less than 200 ml 4. Stable clinical condition with stable dry weight and hematocrit The inclusion and exclusion criteria for the intervention study (March to October 2003), were the same as those for the observation study except that: 5. Only hyperdipsic patients (IDWG % greater than 2%/day) were included 6. Patients using the xerogenic mediations were included if these drugs could be stopped at least 14 days before entering and throughout the interventional study |
| Key exclusion criteria | 1. Haemodynamic instability preventing sufficient ultrafiltration 2. Hospitalisation within the preceding 3 months 3. Dementia or terminal diseases 4. Those not feasible to investigate for logistic reasons 5. Depression or anxiety (which cause xerostomia possibly due to the dysfunction of both brain and salivary glands) 6. Using xerogenic mediations (including anticholinergies, antidepressants, antipsychotics, antihistamines, antiparkinsonian agents, and diuretics) 7. Unwilling to participate in this study |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 31/10/2003 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
138 Shing-Li Road
Tainan
70428
Taiwan
70428
Taiwan
Sponsor information
National Cheng Kung University (Taiwan)
University/education
University/education
138 Shing-Li Road
Tainan
70428
Taiwan
| Website | http://www.ncku.edu.tw/en/ |
|---|---|
"ROR" |
https://ror.org/01b8kcc49 |
Funders
Funder type
Hospital/treatment centre
Cheng Kung University Hospital Research Committee (Taiwan) - research grants (ref: NCKUH-2003-05 and NCKUH-2004-63)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
