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

NCT ID: NCT02210377

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-06-30

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.

Conditions

Intradialytic Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tianjiu (auto-moxibustion)

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.

Group Type: EXPERIMENTAL

Tianjiu

Intervention Type: OTHER

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

Non-Tianjiu (Non auto-MO)

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

Group Type: PLACEBO_COMPARATOR

Placebo (non-Tianjiu)

Intervention Type: OTHER

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

Interventions

Tianjiu

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

Placebo (non-Tianjiu)

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

Intervention Type: OTHER

Other Intervention Names

auto-moxibustion, herbal acupoint paste

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,

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming-Yen Tsai

Department of TCM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ming-Yen Tsai, MS

Role: CONTACT

missuriae@yahoo.com.tw

References

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.

Reference Type: DERIVED

PMID: 37651553 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26966058 (View on PubMed)

Other Identifiers

Chang Gung IRB 102-4749A3

Identifier Type: -

Identifier Source: org_study_id