Brain Tumor Clinical Trial
Official title:
Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
NCT number | NCT02761096 |
Other study ID # | 20152152 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | November 2017 |
Verified date | February 2019 |
Source | Kyunghee University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the effect of acupuncture on inflammation and immune function after craniotomy. This study will be a single-center, parallel group clinical trial that will be conducted at Kyung Hee University Hospital at Gangdong, Seoul, Korea.
Status | Completed |
Enrollment | 44 |
Est. completion date | November 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Participants must meet all of the following criteria in order to be included: 1. planning to undergo regular craniotomy performed for an unruptured aneurysm, facial spasm, or brain tumor; 2. age > 18 years; 3. acupuncture treatment that can start within 48 h after craniotomy; 4. voluntary participation and provision of signed informed consent form. Exclusion Criteria: Participants with any of the following conditions will be excluded: 1. serum C-reactive protein (CRP) level = 1.0 mg/dl before craniotomy; 2. a condition other than an unruptured aneurysm, facial spasm, or brain tumor as an indication for craniotomy; 3. craniotomy performed for infectious brain diseases such as brain abscess or subdural empyema; 4. medication use that can affect the immune system or white blood cell (WBC) count, such as immunosuppressive drugs, steroids, or anticancer drugs or use of these medications within one month prior to the craniotomy; 5. a history of surgery at the same site; 6. emergency surgery; or 7. a severe medical disease, e.g. congestive heart failure, chronic renal failure. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyung Hee University Hospital at Gangdong | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kyunghee University Medical Center | Kyunghee University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum CRP | Turbidimetric immunoassay will be performed for measurement of CRP. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast. | 2 days after surgery | |
Secondary | Serum CRP | Turbidimetric immunoassay will be performed for measurement of CRP. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast. | within 48 h before the surgery, 4 days after surgery and 7 days after surgery | |
Secondary | Serum erythrocyte sedimentation rate (ESR) | The photometrical capillary method will be performed for measurement of ESR. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast. | within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery | |
Secondary | Serum TNF-a | Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast. | within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery | |
Secondary | Serum IL-1ß | Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast. | within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery | |
Secondary | Serum IL-6 | Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast. | within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery | |
Secondary | fever | Any fever with a body temperature over 38? will be recorded on the case report form. | During the post operation day to 7 days after operation day. Body temperature will be measured at 6:00, 10:00, 18:00, and 22:00 every day. | |
Secondary | use of additional antibiotics | Use of additional antibiotics will be recorded on the case report form. | During the post operation day to 7 days after operation day | |
Secondary | infection sign | Infections such as pneumonia or urinary tract infections will be recorded on the case report form. | During the post operation day to 7 days after operation day, |
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