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This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000 system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor resection complicated by cerebral edema, or complex spinal surgery including multi-level scoliosis correction, is a more effective way of monitoring fluid.
We hypothesize that the ability to assess volume status and fluid responsiveness with information gained from Edwards FloTrac/EV1000 system coupled with a goal-directed therapy fluid management algorithm can make a difference in patient outcomes. Our specific aims are:
Outcomes
We will study the consequences of goal-directed fluid therapy that employs use of dynamic indicators seen on FloTrac/EV1000 system by measuring the following:
Pulmonary status
Organ oxygenation
Length of stay (LOS)
Fluid Balance
Hypotension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal Directed Therapy | Experimental | Flotrack monitor is connected and based on what anesthesiologist sees and following study algorithm, anesthesiologist chooses: Phenylephrine, Epinephrine , volume resuscitation (fluids, including normal saline, albumin, voluven and packed red blood cells) and no intervention. |
|
| Control Group | Active Comparator | FloTrac monitor is connected, but he anesthesiologist will not be able to see the monitor although the data will be collected and stored for analysis. Anesthesiologist will be given a study algorithm to follow for the duration of the surgery, and based on it will choose: Phenylephrine, Epinephrine , volume resuscitation (fluids, including normal saline, albumin, voluven and packed red blood cells) and no intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of ICU Stays Greater Than 1.5 Days | the sum of ICU stays greater than the 1.5 Days eligibility for discharge from hospital according to the surgeon, over the course of 20 Days | 20 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine Change | Change in creatinine in the 72 hour post-op period (mg/dL) | Baseline and 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen | We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery. | 1 day |
| Organ Oxygenation as Measured by Serum Lactate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Bloom, MD | New York University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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Patients were prescreened and slate was given to PI for approval. Patients were approached in pre-op on day of surgery in a private setting. Study was discussed with them and questions were answered. If interested, they signed consent.
Study team began screening patients after receiving IRB approval. The first patient was consented on 3/13/14.
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| ID | Title | Description |
|---|---|---|
| FG000 | Goal Directed Therapy | Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Epinephrine | Drug | if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered |
|
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| Albumin | Other | if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered. |
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| Voluven | Other | if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered. |
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| Normal Saline | Other | if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered. |
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| Packed Red Blood Cells | Other | if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered. |
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| FloTrac Monitor | Device | FloTrac monitor is connected for all patients, but only visible to the anesthesiologist for half. Based on a decision tree and the data from monitor, choices of interventions are used. |
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Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery.
| Baseline and 24 Hours |
| Organ Oxygenation as Measured by Arterial Blood Gas Values | Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery. | Baseline and 1 day |
| Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period | Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery. | Baseline and 12 Hours |
| Patients Requiring Fluid Bolus for Management | Number of patients who received fluid boluses in the first 24 hours post-op | 1 day |
| Number of Patients Treated for Hypotension With Phenylephrine Drip | The number of patients on a phenylephrine drip within 24 hours post-op. | 1 day |
| Area Under Curve of MAP Below 65 | Hypotension as measured by area under the curve of MAP less than 65. | 1 Day |
| FG001 | Control Group | FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Goal DIrected Therapy | Anesthesiologist will be able to see the dynamic indicators, and will be given a study algorithm to follow, based on the trending data, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device. |
| BG001 | Control Group | FloTrac will be connected to the monitor, the anesthesiologist will not be able to see the monitor although the data will be collected and stored for analysis. Anesthesiologist will be asked to choose from the same drug and fluid options used in the GDT group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 ICU Stays Greater Than 1.5 Days | the sum of ICU stays greater than the 1.5 Days eligibility for discharge from hospital according to the surgeon, over the course of 20 Days | Posted | Number | 95% Confidence Interval | Number of ICU Stays greater that 1.5 Day | 20 Days |
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| Secondary | Creatinine Change | Change in creatinine in the 72 hour post-op period (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | Baseline and 72 hours |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen | We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery. | Posted | Count of Participants | Participants | 1 day |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Organ Oxygenation as Measured by Serum Lactate | Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 24 Hours |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Organ Oxygenation as Measured by Arterial Blood Gas Values | Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery. | Posted | Mean | Standard Deviation | mEq/L | Baseline and 1 day |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period | Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery. | Data not collected. This outcome measure was not included by PI in reported results | Posted | Mean | Standard Deviation | ml/kg | Baseline and 12 Hours |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Patients Requiring Fluid Bolus for Management | Number of patients who received fluid boluses in the first 24 hours post-op | Posted | Count of Participants | Participants | 1 day |
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| Other Pre-specified | Number of Patients Treated for Hypotension With Phenylephrine Drip | The number of patients on a phenylephrine drip within 24 hours post-op. | Posted | Count of Participants | Participants | 1 day |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Area Under Curve of MAP Below 65 | Hypotension as measured by area under the curve of MAP less than 65. | Posted | Mean | Standard Deviation | mmHG x minutes | 1 Day |
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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 | FloTrac Sensor | FloTrac monitor visible, care based on algorithm and device. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG001 | Control Group | FloTrac monitor not visible, standard of care | 0 | 33 | 0 | 33 | 0 | 33 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Bloom, MD, PHD | NYU School of Medicine | 305 689-2388 | mbloom@miami.edu |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D001929 | Brain Edema |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D054199 | Pseudoephedrine |
| D000082 | Acetaminophen |
| D004837 | Epinephrine |
| D000418 | Albumins |
| C485123 | HES 130-0.4 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011412 | Propanolamines |
| D020005 | Propanols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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