Condition category
Urological and Genital Diseases
Date applied
30/03/2005
Date assigned
19/04/2005
Last edited
15/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Junne-Ming Sung

ORCID ID

Contact details

138 Shing-Li Road
Tainan
70428
Taiwan
+886 6 2353535 ext.2591
jmsung@mail.ncku.edu.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

The study protocol was approved by ethics committees of National Cheng Kung University Hospital and Kuo’s General Hospital, Tainan, Taiwan, and adhered to the Declaration of Helsinki.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Pilocarpine

Primary outcome measures

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 trial start date

01/03/2003

Overall trial end date

31/10/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/03/2003

Recruitment end date

31/10/2003

Locations

Countries of recruitment

Taiwan

Trial participating centre

138 Shing-Li Road
Tainan
70428
Taiwan

Sponsor information

Organisation

National Cheng Kung University (Taiwan)

Sponsor details

138 Shing-Li Road
Tainan
70428
Taiwan

Sponsor type

University/education

Website

http://www.ncku.edu.tw/en/

Funders

Funder type

Hospital/treatment centre

Funder name

Cheng Kung University Hospital Research Committee (Taiwan) - research grants (ref: NCKUH-2003-05 and NCKUH-2004-63)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes