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A Preliminary Randomized Study of Tianjiu (Auto-moxibustion) Effects in Patients With Intradialytic Hypotension

Primary Purpose

Intradialytic Hypotension

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Tianjiu
Placebo (non-Tianjiu)
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intradialytic Hypotension focused on measuring Auto-moxibusition, intra-dialytic hypotension, hemodialysis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subjects enrolled in the study were patients undergo regular hemodialysis, ranging from 20-75 years of age, at nephrologic clinic in KCGMH. These patients have experienced > 3 episodes of intradialytic hypotension in recent two months.

Exclusion Criteria:

  • (1)confounding diseases such as sepsis, cancer, decompensated liver cirrhosis, respiratory failure, and heart failure(NYHA>3), (2) disturbed consciousness, (3) pregnancy, (4) can't tolerate the heat and allergy to automoxibustion,

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tianjiu (auto-moxibustion)

Non-Tianjiu (Non auto-MO)

Arm Description

The participants in the Tianjiu group will be treated with Chinese herbal patches at acupoints on the abdomen and plantar, three times per week, for 4 hours each time during HD.

The participants in the control group will be given placebo patches (brown clay patches) on the same sites.

Outcomes

Primary Outcome Measures

The % of target ultrafiltration achieved
The actual ultrafiltration volume divided by the target ultrafiltration volume

Secondary Outcome Measures

The frequency of IDH episodes and number of nursing interventions during HD sessions
The number of IDH record and related nursing intervention during each H/D session
patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10)
The improvement of subjective symptom
Patients' recovery time from fatigue after dialysis
Recovery time is recorded within minutes, when arriving home, at bed time, the next morning, by next HD

Full Information

First Posted
August 3, 2014
Last Updated
January 28, 2016
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02210377
Brief Title
A Preliminary Randomized Study of Tianjiu (Auto-moxibustion) Effects in Patients With Intradialytic Hypotension
Official Title
Department of Traditional Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Intradialytic hypotension (IDH) is a most frequent complication of hemodialysis (HD) and may contribute to cardiovascular events and high mortality. The etiology of IDH is multifactorial; therefore, it remains a challenging problem in the management of HD patients. Because moxibustion (MO) at specific points can influences hemodynamics, we hypothesize that Tianjiu (auto-MO) at the traditionally used meridian points will reduce the severity of hypotension in patients who undergo HD.
Detailed Description
In this clinical trial, 45 patients had IDH were divided randomly into two (auto-MO therapy and control) groups for 4 weeks. In the Tianjiu (auto-MO) group, the patients were applied at 3 points (Conception Vessel 4, and Kidney 1) for 3-4 h during HD sessions. All number of episodes complicated by symptomatic IDH during HD sessions and the number of IDH-related nursing interventions (Trendelenburg position, manual reduction of ultrafiltration rate, infusion of isotonic saline or hypertonic fluid, lowering of dialysate temperature) in a session were recorded. Pre- and post-dialysis systolic and diastolic BP, pre- and post-dialysis body weights, interdialytic weight gain, percentage of target ultrafiltration achieved, patient's subjective assessment of the degree of fatigue after dialysis (scale from 0 to 10; 0, not at all, 10, extremely) and recovery time from fatigue after dialysis were measured at the 0, 2nd, 4th and 6th week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intradialytic Hypotension
Keywords
Auto-moxibusition, intra-dialytic hypotension, hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tianjiu (auto-moxibustion)
Arm Type
Experimental
Arm Description
The participants in the Tianjiu group will be treated with Chinese herbal patches at acupoints on the abdomen and plantar, three times per week, for 4 hours each time during HD.
Arm Title
Non-Tianjiu (Non auto-MO)
Arm Type
Placebo Comparator
Arm Description
The participants in the control group will be given placebo patches (brown clay patches) on the same sites.
Intervention Type
Other
Intervention Name(s)
Tianjiu
Other Intervention Name(s)
auto-moxibustion, herbal acupoint paste
Intervention Description
After randomization, patients in Tianjiu and placebo (non-Tianjiu) groups will receive 12 sessions of treatment over a 4-week treatment period.The format of the Tianjiu intervention will be the same as in the treatment group. Participants will be instructed to lie supine before their HD session, and then the bilateral KI1 and CV4
Intervention Type
Other
Intervention Name(s)
Placebo (non-Tianjiu)
Intervention Description
The format of the placebo (clay) intervention will be the same as in the treatment group.
Primary Outcome Measure Information:
Title
The % of target ultrafiltration achieved
Description
The actual ultrafiltration volume divided by the target ultrafiltration volume
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The frequency of IDH episodes and number of nursing interventions during HD sessions
Description
The number of IDH record and related nursing intervention during each H/D session
Time Frame
1 year
Title
patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10)
Description
The improvement of subjective symptom
Time Frame
1 year
Title
Patients' recovery time from fatigue after dialysis
Description
Recovery time is recorded within minutes, when arriving home, at bed time, the next morning, by next HD
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subjects enrolled in the study were patients undergo regular hemodialysis, ranging from 20-75 years of age, at nephrologic clinic in KCGMH. These patients have experienced > 3 episodes of intradialytic hypotension in recent two months. Exclusion Criteria: (1)confounding diseases such as sepsis, cancer, decompensated liver cirrhosis, respiratory failure, and heart failure(NYHA>3), (2) disturbed consciousness, (3) pregnancy, (4) can't tolerate the heat and allergy to automoxibustion,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Yen Tsai, MS
Email
missuriae@yahoo.com.tw
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depending on the progress to decide.
Citations:
PubMed Identifier
26966058
Citation
Tsai MY, Su YJ, Ng HY, Chen SY, Huang YC, Wu CH, Chen YH. Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension. BMJ Open. 2016 Mar 10;6(3):e009976. doi: 10.1136/bmjopen-2015-009976.
Results Reference
derived

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A Preliminary Randomized Study of Tianjiu (Auto-moxibustion) Effects in Patients With Intradialytic Hypotension

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