Not provided
Not provided
Not provided
Not provided
Not provided
Minimally invasive surgical methods have ceased enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal Directed Therapy | Active Comparator | In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures. |
|
| Usual Care | No Intervention | Standard of care will be used to manage blood pressures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal Directed Therapy | Device | Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cardiopulmonary Complications | Any documented cardiopulmonary complications present upon chart review. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic Leak Diagnosed Via Radiograph | 7 days | |
| Number of Participants With Renal Injury | 7 days | |
| Death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| George Guldan, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29461 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment was stopped early due to to insufficient enrollment accruals
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Goal Directed Therapy | In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures. Goal Directed Therapy: Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures. |
| FG001 | Usual Care | Standard of care will be used to manage blood pressures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Goal Directed Therapy | In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures. Goal Directed Therapy: Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Cardiopulmonary Complications | Any documented cardiopulmonary complications present upon chart review. | Posted | Count of Participants | Participants | 7 days |
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Goal Directed Therapy | In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures. Goal Directed Therapy: Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Guldan, MD | The Medical University of South Carolina | 843-876-5744 | guldan@musc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2019 | Feb 10, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074388 | Early Goal-Directed Therapy |
| ID | Term |
|---|---|
| D003422 | Critical Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days |
| Length of Intensive Care Unit Stay | 30 days |
| Hospital Length of Stay | 30 days |
| BG001 |
| Usual Care |
Standard of care will be used to manage blood pressures. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Anastomotic Leak Diagnosed Via Radiograph | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Number of Participants With Renal Injury | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Death | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Length of Intensive Care Unit Stay | Posted | Median | 95% Confidence Interval | hours | 30 days |
|
|
|
| Secondary | Hospital Length of Stay | Posted | Median | 95% Confidence Interval | days | 30 days |
|
|
|
| 2 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Usual Care | Standard of care will be used to manage blood pressures. | 1 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |