Decreased salivary flow rate as a dipsogenic factor in haemodialysis patients: a pilocarpine clinical trial

Completed

Conditions: Haemodialysis (HD) patient with large weight gain (>2%/day)
Urological and Genital Diseases
Haemodialysis

Registration Number: ISRCTN41671411

Lead Sponsor: ational Cheng Kung University (Taiwan)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcomes were:<br>1. Changes in the visual analogue scale (VAS) scores of xerostomia, thirst, and stress of fluid restriction<br>2. Unstimulated salivary flow rate (UWS)<br>3. Mean IDWG2days and IDWG3days in each intervention period

Secondary Outcome Measures