Status Approved
First Submitted Date
2019/11/12
Registered Date
2019/11/19
Last Updated Date
2019/11/12
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004451 |
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Unique Protocol ID | CNUHH-2019-186 |
Public/Brief Title | Quantitative analysis for body fluid status during neurosurgery |
Scientific Title | Quantitative analysis for body fluid status during neurosurgery |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | CNUHH-2019-186 |
Approval Date | 2019-11-06 |
Institutional Review Board Name | Institutional review board of Chonnam National University Hwasun Hospital |
Institutional Review Board Address | 322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do |
Institutional Review Board Telephone | 061-379-7598 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Seongheon Lee |
Title | Assistant professor |
Telephone | +82-61-379-8546 |
Affiliation | Chonnam National University Hospital Hwasun Hospital |
Address | 322 Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea |
Contact Person for Public Queries | |
Name | Seongheon Lee |
Title | Assistant professor |
Telephone | +82-61-379-8546 |
Affiliation | Chonnam National University Hospital Hwasun Hospital |
Address | 322 Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea |
Contact Person for Updating Information | |
Name | Seongheon Lee |
Title | Assistant professor |
Telephone | +82-61-379-8546 |
Affiliation | Chonnam National University Hospital Hwasun Hospital |
Address | 322 Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2019-11-18 Anticipated | |
Target Number of Participant | 20 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chonnam National University Hospital Hwasun Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2019-11-18 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Chonnam National University Hospital Hwasun Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chonnam National University Hospital Hwasun Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | For successful fluid therapy, it is helpful to quantify how the administered fluid is distributed and eliminated from the body. Recently introduced fluid kinetics can be used to analyze the disposition of infusion fluids. Moreover, population non-linear mixed effect modeling of fluid kinetics could consider inter-individual variability of surgical patients with different physical characteristics when administering fluids. The inclusion of covariates, such as body weight and blood pressure, in the parameters of the fluid kinetic model may enable the individualized administration of fluids to patients.The aim of this study was to characterize the volume kinetics of fluid administered in patients undergoing neurosurgery by nonlinear mixed effects modeling. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 20 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Patients undergoing neurosurgery |
Cohort/Group Description Measurements of hemoglobin in patients undergoing neurosurgery with craniotomy under general anesthesia |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | adult patients who will have elective neurosurgery under general anesthesia |
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Sampling Method | Non-probability sampling (purposive sampling) |
Condition(s)/Problem(s) |
Not Applicable-Etc
neurosurgery |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~90Year |
|
Description adult patients who will have elective neurosurgery with craniotomy under general anesthesia |
|
Exclusion Criteria |
-American society of anesthesiologists (ASA) Physical status >=3 -Preoperative hemoglobin < 10 g/dl -Blood transfusion before surgery (<24h) -Use of mannitol before surgery -Use of diuretics before surgery -Anticipated massive bleeding during surgery |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Pharmacokinetics | |
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Primary Outcome(s) 1 | ||
Outcome | Hemoglobin |
|
Timepoint | Hemoglobin measurements from induction of anesthesia to the end of surgery (7-14 times) |
|
Secondary Outcome(s) 1 | ||
Outcome | Pharmacokinetic parameters and covariate of non-linear mixed effect model |
|
Timepoint | After population pharmacokinetic analysis |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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