NCT02210377

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

August 3, 2014

Last Update Submit

January 28, 2016

Conditions

Intradialytic Hypotension

Keywords

Auto-moxibusition, intra-dialytic hypotension, hemodialysis

Outcome Measures

Primary Outcomes (1)

  • The % of target ultrafiltration achieved

    The actual ultrafiltration volume divided by the target ultrafiltration volume

    1 year

Secondary Outcomes (3)

  • The frequency of IDH episodes and number of nursing interventions during HD sessions

    1 year

  • patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10)

    1 year

  • Patients' recovery time from fatigue after dialysis

    1 year

Study Arms (2)

Tianjiu (auto-moxibustion)

EXPERIMENTAL

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.

Other: Tianjiu

Non-Tianjiu (Non auto-MO)

PLACEBO COMPARATOR

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

Other: Placebo (non-Tianjiu)

Interventions

TianjiuOTHER

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

Also known as: auto-moxibustion, herbal acupoint paste
Tianjiu (auto-moxibustion)
Placebo (non-Tianjiu)OTHER

The format of the placebo (clay) intervention will be the same as in the treatment group.

Non-Tianjiu (Non auto-MO)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • (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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

Related Publications (2)

  • Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

    PMID: 37651553DERIVED

  • 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.

    PMID: 26966058DERIVED

Central Study Contacts

Ming-Yen Tsai, MS

CONTACT

missuriae@yahoo.com.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of TCM

Study Record Dates

First Submitted

August 3, 2014

First Posted

August 6, 2014

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations

TW(1)