Intracranial Aneurysm, Brain Edema, Scoliosis, Surgery
Conditions
Brief summary
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.
Detailed description
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: * Demonstrate goal-directed therapy (GDT) in fluid management improves peri-operative fluid balance * Demonstrate GDT improves pulmonary function and organ oxygenation * Demonstrate GDT reduces necessary therapeutic interventions in the peri- operative period * Demonstrate GDT reduces hypotensive episodes in the peri-operative period 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 * Time to extubation * Alveolar-arterial (A-a) gradient of oxygen * Requirements for supplemental oxygen * Organ oxygenation * Serum lactate * Arterial blood gas values (pH, HCO3, CO2, O2) * Length of stay (LOS) * In hospital, defined as time from operation start to eligibility for discharge from hospital according to surgeon in accordance with pre-define criteria * In ICU/PACU, defined as time from operation end to eligibility for discharge from intensive care according to attending intensivist in accordance with pre- define criteria * Fluid Balance * Inputs and outputs (I/Os) of all measurable fluids (i.e. blood, crystalloid, colloid) in peri-operative period, through and including duration of intensive care or the next 24-48 hours after completion of surgery * Drugs administered for fluid management (i.e. mannitol, vasopressors) * Pre-operative and post-operative body weights and twice-daily weights via bed weights * Hypotension * Number, duration and severity (i.e. minimum blood pressure) of hypotensive episode, defined as MAP \<65
Interventions
DRUGPhenylephrine
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \< 13 and Cardiac Index is \>=2.2 Phenylephrine is administered
DRUGEpinephrine
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \< 13 and Cardiac Index is \< 2.2 Epinephrine is administered
OTHERAlbumin
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.
OTHERVoluven
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.
OTHERNormal Saline
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.
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.
DEVICEFloTrac Monitor
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Neurosurgical patients with concerns for decreased intracranial compliance; * Orthopedic spine patients; * Patients scheduled to undergo neurosurgical interventions that include any of the following will be eligible: intracranial aneurysm repair; or, major spine surgery.
Exclusion criteria
* Patients with permanent cardiac arrhythmias; * Patients with severe aortic regurgitation; * Patients with intra-aortic balloon pump (IABP); * Patients undergoing emergency surgery; and, * Women who are pregnant and/or nursing will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of ICU Stays Greater Than 1.5 Days | 20 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine Change | Baseline and 72 hours | Change in creatinine in the 72 hour post-op period (mg/dL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Organ Oxygenation as Measured by Serum Lactate | Baseline and 24 Hours | Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery. |
| Organ Oxygenation as Measured by Arterial Blood Gas Values | Baseline and 1 day | Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery. |
| Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period | Baseline and 12 Hours | Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery. |
| Patients Requiring Fluid Bolus for Management | 1 day | Number of patients who received fluid boluses in the first 24 hours post-op |
| Number of Patients Treated for Hypotension With Phenylephrine Drip | 1 day | The number of patients on a phenylephrine drip within 24 hours post-op. |
| Area Under Curve of MAP Below 65 | 1 Day | Hypotension as measured by area under the curve of MAP less than 65. |
| Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen | 1 day | We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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 | 33 |
| Total | 68 |
Baseline characteristics
| Characteristic | Goal DIrected Therapy | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 12 Participants | 10 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 28 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) White | 26 Participants | 24 Participants | 50 Participants |
| Region of Enrollment United States | 35 participants | 33 participants | 68 participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 29 Participants |
| Sex: Female, Male Male | 22 Participants | 17 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 33 |
| other Total, other adverse events | 0 / 35 | 0 / 33 |
| serious Total, serious adverse events | 0 / 35 | 0 / 33 |
Outcome results
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
Time frame: 20 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Goal Directed Therapy | Number of ICU Stays Greater Than 1.5 Days | 13 Number of ICU Stays greater that 1.5 Day |
| Control Group | Number of ICU Stays Greater Than 1.5 Days | 20 Number of ICU Stays greater that 1.5 Day |
Secondary
Creatinine Change
Change in creatinine in the 72 hour post-op period (mg/dL)
Time frame: Baseline and 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal Directed Therapy | Creatinine Change | -0.04 mg/dL | Standard Deviation 0.25 |
| Control Group | Creatinine Change | -0.13 mg/dL | Standard Deviation 0.16 |
Other Pre-specified
Area Under Curve of MAP Below 65
Hypotension as measured by area under the curve of MAP less than 65.
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal Directed Therapy | Area Under Curve of MAP Below 65 | -65.06 mmHG x minutes | Standard Deviation 63.89 |
| Control Group | Area Under Curve of MAP Below 65 | -61.88 mmHG x minutes | Standard Deviation 64.23 |
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.
Time frame: Baseline and 12 Hours
Population: Data not collected. This outcome measure was not included by PI in reported results
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Goal Directed Therapy | Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period | NA ml/kg |
| Control Group | Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period | NA ml/kg |
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.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Goal Directed Therapy | Number of Patients Treated for Hypotension With Phenylephrine Drip | 0 Participants |
| Control Group | Number of Patients Treated for Hypotension With Phenylephrine Drip | 4 Participants |
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.
Time frame: Baseline and 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal Directed Therapy | Organ Oxygenation as Measured by Arterial Blood Gas Values | 3.55 mEq/L | Standard Deviation 3.96 |
| Control Group | Organ Oxygenation as Measured by Arterial Blood Gas Values | 4.75 mEq/L | Standard Deviation 4.45 |
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.
Time frame: Baseline and 24 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal Directed Therapy | Organ Oxygenation as Measured by Serum Lactate | 2.0 mmol/L | Standard Deviation 1.15 |
| Control Group | Organ Oxygenation as Measured by Serum Lactate | 1.75 mmol/L | Standard Deviation 1.04 |
Other Pre-specified
Patients Requiring Fluid Bolus for Management
Number of patients who received fluid boluses in the first 24 hours post-op
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Goal Directed Therapy | Patients Requiring Fluid Bolus for Management | 7 Participants |
| Control Group | Patients Requiring Fluid Bolus for Management | 6 Participants |
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.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Goal Directed Therapy | Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen | 17 Participants |
| Control Group | Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen | 25 Participants |