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| ID | Type | Description | Link |
|---|---|---|---|
| 13-1900 | Other Identifier | COMIRB |
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The purpose of this study is to conduct a prospective, randomized, controlled trial comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive perioperative fluid has been retrospectively implicated in the development postoperative acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid restriction in these patients is not without risk and may compromise end organ perfusion (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic surgery patients will result in better end organ perfusion with fewer occasions of acute kidney injury (AKI) without causing an increase in postoperative acute lung injury or pulmonary edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasmalyte 3ml/kg/hr group | Active Comparator |
| |
| Plasmalyte 6ml/kg/hr group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmalyte 3ml/kg/hr group | Drug | This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of Renal Injury | Acute renal injury as defined by the American Kidney Injury Network (AKIN) criteria in the first 72 hours postoperatively (serum creatinine levels). The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indicating the most severe AKI. (1) Increase ≥ 0.3 mg per dL (26.52 μmol per L) or ≥ 1.5- to twofold from baseline. (2) Increase > two- to threefold from baseline. (3) Increase > threefold from baseline or ≥ 4.0 mg per dL (353.60 μmol per L) with an acute rise of at least 0.5 mg per dL (44.20 μmol per L). | Post-op up to 72 hours |
| Development of Pulmonary Edema | The number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported. | Post-op up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Surgical Intensive Unit Stay/Hospital Stay | Length of Surgical Intensive Unit Stay/Hospital Stay | Up to 7 days |
| Removal of Chest Tubes | Time to removal of Chest Tubes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamas Seres, M.D., PH.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80138 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Plasmalyte 3ml/kg/hr Group | Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them |
| FG001 | Plasmalyte 6ml/kg/hr Group | Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Plasmalyte 3ml/kg/hr Group | Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them |
| BG001 | Plasmalyte 6ml/kg/hr Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Development of Renal Injury | Acute renal injury as defined by the American Kidney Injury Network (AKIN) criteria in the first 72 hours postoperatively (serum creatinine levels). The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indicating the most severe AKI. (1) Increase ≥ 0.3 mg per dL (26.52 μmol per L) or ≥ 1.5- to twofold from baseline. (2) Increase > two- to threefold from baseline. (3) Increase > threefold from baseline or ≥ 4.0 mg per dL (353.60 μmol per L) with an acute rise of at least 0.5 mg per dL (44.20 μmol per L). | Posted | Mean | Standard Deviation | mg/dL | Post-op up to 72 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plasmalyte 3ml/kg/hr Group | Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nick Naughton, Professional Research Assistant | University of Colorado | 3037200833 | nick.naughton@cuanschutz.edu |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Plasmalyte 6ml/kg/hr group | Drug | This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them |
|
| Post-op up to 48 hours |
| Development of Morbidity | Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium | Up to 7 days |
| Death | Death | Assessed up to 30 days Post-op |
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ASA Score | The American Society of Anesthesiology (ASA) Physical Status Classification of the patient's present physical condition on a scale from 1-6 classifications are as follows: ASA 1. Normal healthy patient. ASA 2. Patient with mild systemic disease. ASA 3. Patient with severe systemic disease. ASA 4. Patient with severe systemic disease that is a constant threat to life. ASA 5. Moribund patient who is not expected to survive without the operation. ASA 6. Declared brain-dead patient whose organs are being removed for donor purposes. | Count of Participants | Participants |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Ideal Body Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Body Mass Index (BMI) is weight in kilograms divided by the square of height in meters. Scores between 18.5 and 24.9 indicate healthy body weights. Higher scores indicate higher body weights. | Mean | Standard Deviation | kg/m2 |
|
| Epidural | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| Pulmonary Hypertension | Count of Participants | Participants |
|
| Coronary Artery Disease (CAD) | Count of Participants | Participants |
|
| Hypertension (HTN) | Count of Participants | Participants |
|
| Heart Disease | Count of Participants | Participants |
|
| Peripheral Vascular Disease (PVD) | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Hepatitis | Count of Participants | Participants |
|
| Chronic Kidney Disease (CKD) | Count of Participants | Participants |
|
| Seizure | Count of Participants | Participants |
|
| Lung Cancer | Count of Participants | Participants |
|
| Chronic Lung Infection | Count of Participants | Participants |
|
| Surgical Procedure (Video-Assisted Thoracoscopic Surgery-VATS) | Count of Participants | Participants |
|
| Procedure Duration | Mean | Standard Deviation | min |
|
| Anesthesia Duration | Mean | Standard Deviation | min |
|
| Creatinine | Mean | Standard Deviation | mg/dL |
|
| OG001 | Plasmalyte 6ml/kg/hr Group | Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them |
|
|
|
| Primary | Development of Pulmonary Edema | The number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported. | Posted | Count of Participants | Participants | Post-op up to 72 hours |
|
|
|
| Secondary | Length of Surgical Intensive Unit Stay/Hospital Stay | Length of Surgical Intensive Unit Stay/Hospital Stay | Posted | Mean | Standard Deviation | days | Up to 7 days |
|
|
|
| Secondary | Removal of Chest Tubes | Time to removal of Chest Tubes | Posted | Mean | Standard Deviation | minutes | Post-op up to 48 hours |
|
|
|
| Secondary | Development of Morbidity | Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium | Posted | Count of Participants | Participants | Up to 7 days |
|
|
|
| Secondary | Death | Death | Missing participants lost to follow-up. | Posted | Count of Participants | Participants | Assessed up to 30 days Post-op |
|
|
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| 0 |
| 20 |
| 4 |
| 20 |
| 0 |
| 20 |
| EG001 | Plasmalyte 6ml/kg/hr Group | Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them | 0 | 20 | 5 | 20 | 0 | 20 |
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Supraventricular tachycardia (SVT) | Cardiac disorders | Systematic Assessment |
|
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