Intradialytic HypotensionPhase 2NCT02210377
A Preliminary Randomized Study of Tianjiu (Auto-moxibustion) Effects in Patients With Intradialytic Hypotension
A Phase 2 study testing Tianjiu in people with Intradialytic Hypotension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Intradialytic Hypotension
- What is being tested?
- Tianjiu
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- (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,
Trial locations and contacts
1 site in 1 country.
Ming-Yen Tsai, MS contact
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
About this study
Official title: Department of Traditional Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung
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.
Read the 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.
- Conditions
- Intradialytic Hypotension
- Being tested
- Tianjiu, Placebo (non-Tianjiu)
- Keywords
- Auto-moxibusition, intra-dialytic hypotension, hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TianjiuOther
Also called auto-moxibustion, herbal acupoint paste
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
Placebo (non-Tianjiu)Other
The format of the placebo (clay) intervention will be the same as in the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo (non-Tianjiu) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The % of target ultrafiltration achieved
The actual ultrafiltration volume divided by the target ultrafiltration volume
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10)
The improvement of subjective symptom
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Yen Tsai, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210377
- Sponsor's protocol ID
- Chang Gung IRB 102-4749A3
- Status last verified
- Jan 2016
- First submitted
- 3 Aug 2014
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Depending on the progress to decide.
Publications
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.
PubMed 37651553Tsai 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.
PubMed 26966058
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Traditional Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung
- ClinicalTrials.gov ID
- NCT02210377
- Acronym / sponsor ID
- Chang Gung IRB 102-4749A3
- Conditions
- Intradialytic Hypotension
- Keywords
- Auto-moxibusition, intra-dialytic hypotension, hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tianjiu (auto-moxibustion) | Experimental | Other: TianjiuThe 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. |
| Non-Tianjiu (Non auto-MO) | Placebo comparator | Other: Placebo (non-Tianjiu)The participants in the control group will be given placebo patches (brown clay patches) on the same sites. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TianjiuAlso: auto-moxibustion, herbal acupoint pasteAfter 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 | Other | Tianjiu (auto-moxibustion) |
| Placebo (non-Tianjiu)The format of the placebo (clay) intervention will be the same as in the treatment group. | Other | Non-Tianjiu (Non auto-MO) |
Primary outcome
The % of target ultrafiltration achieved
Time frame: 1 year
The actual ultrafiltration volume divided by the target ultrafiltration volume
3 secondary outcomes
The frequency of IDH episodes and number of nursing interventions during HD sessions
Time frame: 1 year
patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10)
Time frame: 1 year
Patients' recovery time from fatigue after dialysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Derived from this study: PubMed 37651553Natale 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.
- Derived from this study: PubMed 26966058Tsai 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.
- Individual participant dataSharing planned: Undecided. Depending on the progress to decide.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Yen Tsai, MS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tianjiu in people with Intradialytic Hypotension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yen Tsai, MS (missuriae@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The % of target ultrafiltration achieved (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02210377, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.