Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)
NCT ID: NCT02742974
Last Updated: 2016-04-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
196 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-12-31
Study Completion Date
2019-12-31
Brief Summary
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The aim of this study is to determine if the incidence of post-operative complications can be decreased by the implementation of intra-operative, minimally invasive hemodynamic monitoring (MIHM) via FloTrac™ and EV1000™ in trauma patients.
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Detailed Description
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Numerous factors are known to contribute to post-traumatic morbidity and mortality. Acute blood loss, hypovolemia, and systemic inflammatory response syndrome can often develop following severe traumatic injury and are, frequently, further exacerbated by the presence of pre-existing health conditions. The culmination of these insults and/or pre-existing conditions can precipitate an imbalance in oxygen delivery and consumption leading to tissue ischemia and resultant organ dysfunction.
Tissue ischemia precipitates a disruption in the balance of oxygen delivery and consumption often yielding a conversion from aerobic to anaerobic processes in order to maintain metabolic functionality. The conversion to anaerobic processes leads to the production of lactic acid and a resulting consumption of the body's basic buffers. Clinically, the consumption of the body's basic buffers is frequently referred to as the development of a base deficit. Both the production of lactic acid and the development of a base deficit have been positively linked to the increased morbidity and mortality in multiple critically ill patient populations, including those with traumatic injuries.
Multiple studies have linked the rate at which base deficit corrects or lactic acid clears to the likelihood of survival. Accordingly, hemodynamic monitoring can provide vital information concerning cardiovascular function including vascular volume, vascular capacitance, and cardiac performance. Obtaining this information enables clinicians to tailor interventions to target specific components of the cardiovascular system in order to most effectively reverse the cause of tissue hypoxia, elevation in lactic acid, and base deficit, while simultaneously decreasing the likelihood of causing harm through unnecessary or unwarranted changes in management.
Advancements in hemodynamic monitoring technology now allow clinicians to obtain data by using minimally invasive techniques. Devices utilizing this technology can be connected to vascular access routinely utilized in the intensive care setting such as arterial lines. These devices provide parameters such as systolic pressure variation (SPV), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness of critically ill, mechanically ventilated patients. Studies evaluating these parameters have shown them to have a 84-94% positive predictive value for fluid responsiveness. In addition, higher variability in studied parameters were indicative of patients who were more likely to be responsive to fluid challenges.
Modern clinical management in critically ill patients with cardiovascular dysfunction hinges on reversal of the underlying cause of cardiovascular dysfunction. Recent management strategies have used a multi-faceted approach in which multiple processes of potential dysfunction can be monitored and managed simultaneously. Management is goal directed with clearly defined endpoints for the management of vascular volume, cardiac performance as well as maintenance of vascular capacitance. Hemodynamic monitoring technology is essential in providing data that will allow clinical interventions to be tailored to patient-specific physiology and provide goals for titration of therapy.
In recent years, data has emerged using goal directed therapy in the surgical patient population with favorable outcomes suggesting a decrease in post-operative organ dysfunction, ICU and hospital length of stay, however, there is limited data in the trauma patient population. This study endeavors to determine if the implementation of intra-operative monitoring will decrease the incidence of post-operative complications such as acute lung injury, infections, thromboembolism, cerebral vascular accident, acute kidney injury, myocardial infarction; in addition to the traditional outcome measures of mortality and length of stay.
Tissue ischemia precipitates a disruption in the balance of oxygen delivery and consumption often yielding a conversion from aerobic to anaerobic processes in order to maintain metabolic functionality. The conversion to anaerobic processes leads to the production of lactic acid and a resulting consumption of the body's basic buffers. Clinically, the consumption of the body's basic buffers is frequently referred to as the development of a base deficit. Both the production of lactic acid and the development of a base deficit have been positively linked to the increased morbidity and mortality in multiple critically ill patient populations, including those with traumatic injuries.
Multiple studies have linked the rate at which base deficit corrects or lactic acid clears to the likelihood of survival. Accordingly, hemodynamic monitoring can provide vital information concerning cardiovascular function including vascular volume, vascular capacitance, and cardiac performance. Obtaining this information enables clinicians to tailor interventions to target specific components of the cardiovascular system in order to most effectively reverse the cause of tissue hypoxia, elevation in lactic acid, and base deficit, while simultaneously decreasing the likelihood of causing harm through unnecessary or unwarranted changes in management.
Advancements in hemodynamic monitoring technology now allow clinicians to obtain data by using minimally invasive techniques. Devices utilizing this technology can be connected to vascular access routinely utilized in the intensive care setting such as arterial lines. These devices provide parameters such as systolic pressure variation (SPV), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness of critically ill, mechanically ventilated patients. Studies evaluating these parameters have shown them to have a 84-94% positive predictive value for fluid responsiveness. In addition, higher variability in studied parameters were indicative of patients who were more likely to be responsive to fluid challenges.
Modern clinical management in critically ill patients with cardiovascular dysfunction hinges on reversal of the underlying cause of cardiovascular dysfunction. Recent management strategies have used a multi-faceted approach in which multiple processes of potential dysfunction can be monitored and managed simultaneously. Management is goal directed with clearly defined endpoints for the management of vascular volume, cardiac performance as well as maintenance of vascular capacitance. Hemodynamic monitoring technology is essential in providing data that will allow clinical interventions to be tailored to patient-specific physiology and provide goals for titration of therapy.
In recent years, data has emerged using goal directed therapy in the surgical patient population with favorable outcomes suggesting a decrease in post-operative organ dysfunction, ICU and hospital length of stay, however, there is limited data in the trauma patient population. This study endeavors to determine if the implementation of intra-operative monitoring will decrease the incidence of post-operative complications such as acute lung injury, infections, thromboembolism, cerebral vascular accident, acute kidney injury, myocardial infarction; in addition to the traditional outcome measures of mortality and length of stay.
Conditions
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Critical Illness
Trauma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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FloTrac™ and EV1000™ pre and post-operatively
Cardiovascular management guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ will be utilized in the pre and post-operative period in the control arm.
Group Type
NO_INTERVENTION
No interventions assigned to this group
FloTrac™ and EV1000™ peri-operatively
Cardiovascular management guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ will be utilized in the perioperative period for the intervention arm
Group Type
EXPERIMENTAL
FloTrac™ and EV1000™
Intervention Type
DEVICE
Interventions to improve cardiovascular performance will be made in all patients whose cardiovascular function is sub-optimal in accordance with routine clinical management during trauma resuscitation. Patients who meet inclusion criteria will be assigned to the intervention or control arm of the study based on the process outlined in the protocol. Patients assigned to the intervention arm will have intra-operative hemodynamic monitoring performed by the anesthesia staff and cardiovascular interventions will be based off of the algorithm described in the protocol. Members of anesthesia or the surgical team can initiate interventions as indicated during routine ICU care or intra-operatively.
Interventions
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FloTrac™ and EV1000™
Interventions to improve cardiovascular performance will be made in all patients whose cardiovascular function is sub-optimal in accordance with routine clinical management during trauma resuscitation. Patients who meet inclusion criteria will be assigned to the intervention or control arm of the study based on the process outlined in the protocol. Patients assigned to the intervention arm will have intra-operative hemodynamic monitoring performed by the anesthesia staff and cardiovascular interventions will be based off of the algorithm described in the protocol. Members of anesthesia or the surgical team can initiate interventions as indicated during routine ICU care or intra-operatively.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. 18 years of age or older
2. Injury Severity Score \> 15 (indicator of anticipated trauma mortality)
3. Admission to Surgical-Trauma ICU (STICU)
4. Anticipated surgery within 72 hours of admission
5. American Society of Anesthesiology patient classification status (ASA) 2-5
6. Lactic acid \> 2.5 within 24 hours of surgical procedure or Base deficit ≥ - 5 mmol/L, or persistent requirement for vasopressor support within 24 hours of surgical procedure
7. Patient requires mechanical ventilation prior to consenting surgery
8. Vascular devices that include a minimum of an arterial line
9. Minimally invasive hemodynamic monitoring initiated prior to first surgical procedure unless patient is taken emergently, e.g. OR from trauma bay
10. Patients requiring emergent initial operative procedures will be eligible for consenting if above criteria are met prior to their second surgical procedure
11. Anticipated operative procedure precipitating evaluation and/or consenting for study must be \> 30 minutes in duration
* Procedures \< 30 minutes would not result in significant metabolic stress necessitating a continuation of MIHM
2. Injury Severity Score \> 15 (indicator of anticipated trauma mortality)
3. Admission to Surgical-Trauma ICU (STICU)
4. Anticipated surgery within 72 hours of admission
5. American Society of Anesthesiology patient classification status (ASA) 2-5
6. Lactic acid \> 2.5 within 24 hours of surgical procedure or Base deficit ≥ - 5 mmol/L, or persistent requirement for vasopressor support within 24 hours of surgical procedure
7. Patient requires mechanical ventilation prior to consenting surgery
8. Vascular devices that include a minimum of an arterial line
9. Minimally invasive hemodynamic monitoring initiated prior to first surgical procedure unless patient is taken emergently, e.g. OR from trauma bay
10. Patients requiring emergent initial operative procedures will be eligible for consenting if above criteria are met prior to their second surgical procedure
11. Anticipated operative procedure precipitating evaluation and/or consenting for study must be \> 30 minutes in duration
* Procedures \< 30 minutes would not result in significant metabolic stress necessitating a continuation of MIHM
Exclusion Criteria
1. Pregnancy
2. Exclusions due to limitations with respect to accuracy of MIHM:
* Patients not intubated prior to surgical procedure
* Patients requiring an open thoracotomy
* Patients with known history of surgical intervention for peripheral vascular disease
* Patients with pre-existing atrial arrhythmias
* Patients who are on cardiopulmonary bypass
3. Isolated acute cerebral injury and/or traumatic cerebral injury
* Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing intracranial pressures
4. Cardiac arrest prior to enrollment
5. Patients with pre-existing, dialysis dependent, renal failure upon admission
* Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing renal failure
6. Patients with pre-existing cirrhosis
* Hepatic failure results in abnormal clearance of lactic acid
7. Patients with no survival injuries, e.g. gunshot wound to the head
2. Exclusions due to limitations with respect to accuracy of MIHM:
* Patients not intubated prior to surgical procedure
* Patients requiring an open thoracotomy
* Patients with known history of surgical intervention for peripheral vascular disease
* Patients with pre-existing atrial arrhythmias
* Patients who are on cardiopulmonary bypass
3. Isolated acute cerebral injury and/or traumatic cerebral injury
* Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing intracranial pressures
4. Cardiac arrest prior to enrollment
5. Patients with pre-existing, dialysis dependent, renal failure upon admission
* Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing renal failure
6. Patients with pre-existing cirrhosis
* Hepatic failure results in abnormal clearance of lactic acid
7. Patients with no survival injuries, e.g. gunshot wound to the head
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Sponsor Role
collaborator
CAMC Health System
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Audis Bethea, PharmD, BCPS
Role: PRINCIPAL_INVESTIGATOR
CAMC Health System
Locations
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Charleston Area Medical Center, General Hospital
Charleston, West Virginia, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Husain FA, Martin MJ, Mullenix PS, Steele SR, Elliott DC. Serum lactate and base deficit as predictors of mortality and morbidity. Am J Surg. 2003 May;185(5):485-91. doi: 10.1016/s0002-9610(03)00044-8.
Reference Type
RESULT
Abramson D, Scalea TM, Hitchcock R, Trooskin SZ, Henry SM, Greenspan J. Lactate clearance and survival following injury. J Trauma. 1993 Oct;35(4):584-8; discussion 588-9. doi: 10.1097/00005373-199310000-00014.
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RESULT
Cerovic O, Golubovic V, Spec-Marn A, Kremzar B, Vidmar G. Relationship between injury severity and lactate levels in severely injured patients. Intensive Care Med. 2003 Aug;29(8):1300-5. doi: 10.1007/s00134-003-1753-8. Epub 2003 Jul 9.
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Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, Parrillo JE, Dellinger RP, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock. 2009 Jul;32(1):35-9. doi: 10.1097/shk.0b013e3181971d47.
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Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, Tomlanovich MC. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004 Aug;32(8):1637-42. doi: 10.1097/01.ccm.0000132904.35713.a7.
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Callaway DW, Shapiro NI, Donnino MW, Baker C, Rosen CL. Serum lactate and base deficit as predictors of mortality in normotensive elderly blunt trauma patients. J Trauma. 2009 Apr;66(4):1040-4. doi: 10.1097/TA.0b013e3181895e9e.
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Dunne JR, Tracy JK, Scalea TM, Napolitano LM. Lactate and base deficit in trauma: does alcohol or drug use impair their predictive accuracy? J Trauma. 2005 May;58(5):959-66. doi: 10.1097/01.ta.0000158508.84009.49.
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Ouellet JF, Roberts DJ, Tiruta C, Kirkpatrick AW, Mercado M, Trottier V, Dixon E, Feliciano DV, Ball CG. Admission base deficit and lactate levels in Canadian patients with blunt trauma: are they useful markers of mortality? J Trauma Acute Care Surg. 2012 Jun;72(6):1532-5. doi: 10.1097/TA.0b013e318256dd5a.
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RESULT
Ziegler DW, Wright JG, Choban PS, Flancbaum L. A prospective randomized trial of preoperative "optimization" of cardiac function in patients undergoing elective peripheral vascular surgery. Surgery. 1997 Sep;122(3):584-92. doi: 10.1016/s0039-6060(97)90132-x.
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Otero RM, Nguyen HB, Huang DT, Gaieski DF, Goyal M, Gunnerson KJ, Trzeciak S, Sherwin R, Holthaus CV, Osborn T, Rivers EP. Early goal-directed therapy in severe sepsis and septic shock revisited: concepts, controversies, and contemporary findings. Chest. 2006 Nov;130(5):1579-95. doi: 10.1378/chest.130.5.1579.
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Monnet X, Dres M, Ferre A, Le Teuff G, Jozwiak M, Bleibtreu A, Le Deley MC, Chemla D, Richard C, Teboul JL. Prediction of fluid responsiveness by a continuous non-invasive assessment of arterial pressure in critically ill patients: comparison with four other dynamic indices. Br J Anaesth. 2012 Sep;109(3):330-8. doi: 10.1093/bja/aes182. Epub 2012 Jun 26.
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Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
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RESULT
Vincent JL, Weil MH. Fluid challenge revisited. Crit Care Med. 2006 May;34(5):1333-7. doi: 10.1097/01.CCM.0000214677.76535.A5.
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RESULT
Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.
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RESULT
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Bishop MH, Shoemaker WC, Appel PL, Meade P, Ordog GJ, Wasserberger J, Wo CJ, Rimle DA, Kram HB, Umali R, et al. Prospective, randomized trial of survivor values of cardiac index, oxygen delivery, and oxygen consumption as resuscitation endpoints in severe trauma. J Trauma. 1995 May;38(5):780-7. doi: 10.1097/00005373-199505000-00018.
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Benes J, Chytra I, Altmann P, Hluchy M, Kasal E, Svitak R, Pradl R, Stepan M. Intraoperative fluid optimization using stroke volume variation in high risk surgical patients: results of prospective randomized study. Crit Care. 2010;14(3):R118. doi: 10.1186/cc9070. Epub 2010 Jun 16.
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RESULT
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Related Links
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http://clincalc.com/IcuMortality/SOFA.aspx
SOFA Calculator
http://clincalc.com/IcuMortality/APACHEII.aspx
APACHE II Calculator
Other Identifiers
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15-159
Identifier Type: -
Identifier Source: org_study_id
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