Status Approved
First Submitted Date
2016/08/23
Registered Date
2016/09/19
Last Updated Date
2016/09/06
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002062 |
---|---|
Unique Protocol ID | KUH1160103 |
Public/Brief Title | The correlation between the change in thoracic fluid content and the change in patient body weight in Fontan procedure |
Scientific Title | The correlation between the change in thoracic fluid content and the change in patient body weight in Fontan procedure |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | KUH1160103 |
Approval Date | 2016-08-03 |
Institutional Review Board Name | Institutional Review Board of Konkuk University Medical Center |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Woon-Seok Kang |
Title | |
Telephone | |
Affiliation | Konkuk University Medical Center |
Address | 120-1 Neungdongro Gwangjingu Seoul |
Contact Person for Public Queries | |
Name | Woon-Seok Kang |
Title | |
Telephone | |
Affiliation | Konkuk University Medical Center |
Address | 120-1 Neungdongro Gwangjingu Seoul |
Contact Person for Updating Information | |
Name | Woon-Seok Kang |
Title | |
Telephone | |
Affiliation | Konkuk University Medical Center |
Address | 120-1 Neungdongro Gwangjingu Seoul |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-08-05 Actual | |
Target Number of Participant | 25 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Konkuk University Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-08-05 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Konkuk University Medical Center |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Konkuk University Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Determination of exact patients’ volume status and appropriate strategy for fluid management during pediatric cardiac surgery are critical factors to obtain stable hemodynamic status and better clinical outcome. It is even more important than in adult cardiac surgery because the large amounts of fluid shifts compared to the patient’s small body surface area can occur. In addition, the inflammatory reactions by the operation of cardiopulmonary bypass (CPB) can aggravate the patient’s unstable hemodynamic state. Traditional method to evaluate volume status in adult patients is measurement of central venous pressure (CVP) or pulmonary capillary wedge pressure (PCWP). In pediatric patients, CVP also has been widely used to estimate intravascular volume status. However, its use as a marker of exact volume status is inappropriate because of the various factors to affect the accuracy such as venous capacitance, cardiac chamber compliance, cardiac valve competence and pulmonary artery pressure. In addition, the patient’s small size or aberrant anatomy make difficulty to insert a pulmonary artery catheter for PCWP measurement in pediatric patients who have congenital heart disease, and this procedure has a high risk of complications such as rupture of pulmonary artery. In the pediatric patients undergoing Fontan procedure, it is more difficult to evaluate the patient’s exact volume status by using CVP measurement because the value of CVP indicates the pulmonary arterial pressure in post-operative period. Therefore, if there is good indicator of patients’ volume status, it will be useful for fluid management in the patients undergoing Fontan procedure. The values of thoracic fluid content (TFC) and percentage change in TFC compared with baseline (TFCd0%) derived by the bioreactance technique using non-invasive cardiac output monitoring (NICOM) device already showed good correlation with the amount of fluid removal in patients undergoing hemodialysis and with intraoperative fluid balance in patients undergoing pediatric cardiac surgery. Therefore, we hypothesized that TFC or TFCd0% might be also a useful indicator for fluid management in pediatric patients undergoing Fontan procedure. The aim of this study was to evaluate the utility of TFC or TFCd0% in intraoperative fluid management and its clinical application. Thus, the values of TFC, changes in TFC, intraoperative fluid balance, and changes in body weight were analyzed to evaluate the correlations among them. |
---|
8. Study Design
Study Type | Observational Study |
---|---|
Observational Study Model | Cohort |
Time Perspective | Retrospective |
Target Number of Participant | 25 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label medical records including anesthetic and operative records of patients who had elective Fontan procedure due to congenital functional single ventricle |
Cohort/Group Description medical records including anesthetic and operative records of patients who had elective Fontan procedure due to congenital functional single ventricle from april 2011 to december 2015 - hemodynamic variables measured by non-invasive and invasive monitoring, various variables such as cardiac output, stroke volume, stroke volume variation, thoracic fluid content measured by non-invasive cardiac output monitoring, patients' body weight and intraoperative fluid balance which were recorded at two time points (after anesthetic induction and just before transfer to SICU) |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | patients who had elective Fontan procedure due to congenital functional single ventricle in Konkuk University Medical Center from April 2011 to December 2015 |
---|---|
Sampling Method | By using non-probablity sampling method, patients who had elective Fontan procedure due to congenital functional single ventricle in Konkuk University Medical Center from April 2011 to December 2015 were reviewed retrospectively |
Condition(s)/Problem(s) |
* (Q00-Q99)Congenital malformations, deformations and chromosomal abnormalities (Q24.9)Congenital malformation of heart, unspecified |
Rare Disease | Yes |
Inclusion Criteria |
Gender Both |
Age 1Year~4Year |
|
Description patients who had elective Fontan procedure due to congenital functional single ventricle in Konkuk University Medical Center from April 2011 to December 2015 |
|
Exclusion Criteria |
incomplete medical record |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Thoracic fluid content |
|
Timepoint | at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU |
|
Primary Outcome(s) 2 | ||
Outcome | Body weight of patient |
|
Timepoint | at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU |
|
Primary Outcome(s) 3 | ||
Outcome | intraoperative fluid balance (Input/Output) |
|
Timepoint | just before departure from the operating room to the ICU |
|
Primary Outcome(s) 4 | ||
Outcome | TFCd0% |
|
Timepoint | at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU |
|
Secondary Outcome(s) 1 | ||
Outcome | Mean arterial blood pressure |
|
Timepoint | at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU |
|
Secondary Outcome(s) 2 | ||
Outcome | Heart rate |
|
Timepoint | at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU |
|
Secondary Outcome(s) 3 | ||
Outcome | central venous pressure |
|
Timepoint | at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU |
|
Secondary Outcome(s) 4 | ||
Outcome | Cardiac output and cardiac index |
|
Timepoint | at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU |
|
Secondary Outcome(s) 5 | ||
Outcome | Stroke volume variation |
|
Timepoint | at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU |
11. Study Results and Publication
Result Registered |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
---|
TOP
BOTTOM
화면 최하단으로 이동