Intracranial AneurysmNCT02701582
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
A study testing Phenylephrine, Epinephrine and Albumin in people with Intracranial Aneurysm and Brain Edema, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Intracranial Aneurysm, Brain Edema, Scoliosis
- What is being tested?
- Phenylephrine, Epinephrine and Albumin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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
- Conditions
- Intracranial Aneurysm, Brain Edema, Scoliosis, Surgery
- Being tested
- Phenylephrine, Epinephrine, Albumin, Voluven, Normal Saline
- Medical subject headings
- Intracranial Aneurysm, Brain Edema, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Sudafed, Neo-Synephrine, SudoGest
if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered
EpinephrineDrug
Also called EpiPen, Adrenaclick, Medihaler-Epi
if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered
AlbuminOther
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.
VoluvenOther
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.
Normal SalineOther
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.
Packed Red Blood CellsOther
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.
FloTrac MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Phenylephrine; Drug: Epinephrine; Other: Albumin; Other: Voluven; Other: Normal Saline; Other: Packed Red Blood Cells; Device: FloTrac Monitor |
| 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. Receives: Drug: Phenylephrine; Drug: Epinephrine; Other: Albumin; Other: Voluven; Other: Normal Saline; Other: Packed Red Blood Cells; Device: FloTrac Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 Days
Secondary outcomes (1)
Creatinine Change
Change in creatinine in the 72 hour post-op period (mg/dL)
Measured: Baseline and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2014
- Primary completionJan 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Bloom, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701582
- Sponsor's protocol ID
- 13-01043
- Status last verified
- Aug 2019
- First submitted
- 22 Feb 2016
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT02701582
- Acronym / sponsor ID
- 13-01043
- Conditions
- Intracranial Aneurysm, Brain Edema, Scoliosis, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Directed Therapy | Experimental | Drug: Phenylephrine, Drug: Epinephrine, Other: Albumin, Other: Voluven, Other: Normal Saline, Other: Packed Red Blood Cells, Device: FloTrac MonitorFlotrack 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 | Drug: Phenylephrine, Drug: Epinephrine, Other: Albumin, Other: Voluven, Other: Normal Saline, Other: Packed Red Blood Cells, Device: FloTrac MonitorFloTrac 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenylephrineAlso: Sudafed, Neo-Synephrine, SudoGestif Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered | Drug | Control Group, Goal Directed Therapy |
| EpinephrineAlso: EpiPen, Adrenaclick, Medihaler-Epiif Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered | Drug | Control Group, Goal Directed Therapy |
| Albuminif 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. | Other | Control Group, Goal Directed Therapy |
| Voluvenif 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. | Other | Control Group, Goal Directed Therapy |
| Normal Salineif 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. | Other | Control Group, Goal Directed Therapy |
| Packed Red Blood Cellsif 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. | Other | Control Group, Goal Directed Therapy |
| FloTrac MonitorFloTrac 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. | Device | Control Group, Goal Directed Therapy |
Primary outcome
Number of ICU Stays Greater Than 1.5 Days
Time frame: 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
1 secondary outcome
Creatinine Change
Time frame: Baseline and 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Bloom, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine, Epinephrine and Albumin in people with Intracranial Aneurysm and Brain Edema, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ICU Stays Greater Than 1.5 Days (time frame: 20 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.