Critical IllnessFROSTNCT02742974
Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)
A study testing Device: FloTrac™ and EV1000™, Volume Challenge and Vasopressor Therapy in people with Critical Illness and Trauma, run by CAMC Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Trauma
- What is being tested?
- Device: FloTrac™ and EV1000™, Volume Challenge and Vasopressor Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Injury Severity Score > 15 (indicator of anticipated trauma mortality)
- Admission to Surgical-Trauma ICU (STICU)
- Anticipated surgery within 72 hours of admission
- American Society of Anesthesiology patient classification status (ASA) 2-5
- 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
Show all 12Show fewer
- Patient requires mechanical ventilation prior to consenting surgery
- Vascular devices that include a minimum of an arterial line
- Minimally invasive hemodynamic monitoring initiated prior to first surgical procedure unless patient is taken emergently, e.g. OR from trauma bay
- Patients requiring emergent initial operative procedures will be eligible for consenting if above criteria are met prior to their second surgical procedure
- 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
Who cannot join
- Pregnancy
- 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
Show all 15Show fewer
- Patients who are on cardiopulmonary bypass
- 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
- Cardiac arrest prior to enrollment
- 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
- Patients with pre-existing cirrhosis
- Hepatic failure results in abnormal clearance of lactic acid
- Patients with no survival injuries, e.g. gunshot wound to the head
Trial locations and contacts
1 site in 1 country.
United States1 site
Charleston Area Medical Center, General Hospital
Charleston, West Virginia, 25301
About this study
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.
Read the detailed description
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.
- Conditions
- Critical Illness, Trauma
- Being tested
- Device: FloTrac™ and EV1000™, Volume Challenge, Vasopressor Therapy, Inotropic Therapy
- Keywords
- Trauma, Minimally Invasive Hemodynamic Monitoring, Perioperative, Complications, Hemodynamics, Operative procedures
- Medical subject headings
- Critical Illness, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: FloTrac™ and EV1000™Device
Minimally invasive hemodynamic monitoring utilizing the FloTrac sensor and EV1000 platform to continuously assess cardiovascular parameters for clinical management.
Volume ChallengeOther
Protocol-directed fluid administration for optimization of stroke volume variation and cardiac performance. Volume challenge options included crystalloids (normal saline, hypertonic saline, lactated Ringer's), blood products, and albumin
Vasopressor TherapyDrug
Protocol-directed vasopressor administration based on hemodynamic monitoring data. Agents included norepinephrine, phenylephrine, epinephrine, dopamine, and vasopressin.
Inotropic TherapyDrug
Protocol-directed inotropic support based on hemodynamic monitoring data. Agents included dobutamine and dopamine.
| Study group | Role | What they receive |
|---|---|---|
| FloTrac™ and EV1000™ pre and post-operatively | Active comparator | Cardiovascular interventions guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ in the pre and post-operative period in the control arm. Receives: Device: Device: FloTrac™ and EV1000™ |
| FloTrac™ and EV1000™ peri-operatively | Experimental | Cardiovascular interventions guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ in the perioperative period for the intervention arm Receives: Device: Device: FloTrac™ and EV1000™; Other: Volume Challenge; Drug: Vasopressor Therapy; Drug: Inotropic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
The aim of this study is to determine if the incidence of post-operative complications will decreased with the implementation of intra-operative, minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ in trauma patients.
Measured: Post-operative complications during patient hospital stay up to 6 months
Secondary outcomes (7)
Impact of Intervention on ICU/Hospital mortality rate
To evaluate the impact of continuing intra-operative minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ :
-ICU and hospital mortality rate
Measured: During patient hospital stay up to 6 months
SOFA scores
Sepsis-related Organ Failure (SOFA) score between study cohorts. These scores will be recorded in whole numbers.
Measured: Within 24 hours pre and post-surgery
Changes in pre and post-operative lactic acid and base deficit
To compare changes in pre and post-operative lactic acid and based deficit between cohorts based on duration of surgical interventions. Both lactic acid and base deficit values will be recorded in mmoL/L.
Measured: Within 24 hours pre and post-surgery
Changes in pre and post-operative APACHE II score
To compare changes in pre and post-operative APACHE II scores between cohorts based on duration of surgical interventions. This score will be recorded in whole numbers.
Measured: Within 24 hours pre and post-surgery
ICU Length of Stay
Duration of stay in the ICU following surgery
Measured: Through ICU discharge, an average of 30 days
Duration of Post-operative Vasopressor Requirement
Need for vasopressor therapy following surgery
Measured: From completion of surgery until vasopressor discontinuation or hospital discharge (up to 6 months)
Hospital length of stay
Duration of hospitalization following surgery
Measured: During hospitalization up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: Lack of research personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Audis Bethea, PharmD, BCPS, Principal investigator, CAMC Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742974
- Sponsor's protocol ID
- 15-159
- Acronym
- FROST
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2016
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12727572Abramson 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.
PubMed 8411283Cerovic 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.
PubMed 12904861Arnold 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.
PubMed 19533847Nguyen 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.
PubMed 15286537Callaway 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.
PubMed 19359912Dunne 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.
PubMed 15920409Ouellet 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.
PubMed 22695417Ziegler 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.
PubMed 9308617Landry DW, Oliver JA. The pathogenesis of vasodilatory shock. N Engl J Med. 2001 Aug 23;345(8):588-95. doi: 10.1056/NEJMra002709. No abstract available.
PubMed 11529214Otero 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.
PubMed 17099041Monnet 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.
PubMed 22735299Marik 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.
PubMed 19602972Vincent JL, Weil MH. Fluid challenge revisited. Crit Care Med. 2006 May;34(5):1333-7. doi: 10.1097/01.CCM.0000214677.76535.A5.
PubMed 16557164Osman 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.
PubMed 17080001
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)
- ClinicalTrials.gov ID
- NCT02742974
- Acronym / sponsor ID
- FROST / 15-159
- Conditions
- Critical Illness, Trauma
- Keywords
- Trauma, Minimally Invasive Hemodynamic Monitoring, Perioperative, Complications, Hemodynamics, Operative procedures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of research personnel
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Oct 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FloTrac™ and EV1000™ pre and post-operatively | Active comparator | Device: Device: FloTrac™ and EV1000™Cardiovascular interventions guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ in the pre and post-operative period in the control arm. |
| FloTrac™ and EV1000™ peri-operatively | Experimental | Device: Device: FloTrac™ and EV1000™, Other: Volume Challenge, Drug: Vasopressor Therapy, Drug: Inotropic TherapyCardiovascular interventions guided by minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ in the perioperative period for the intervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 years of age or older
- Injury Severity Score > 15 (indicator of anticipated trauma mortality)
- Admission to Surgical-Trauma ICU (STICU)
- Anticipated surgery within 72 hours of admission
- American Society of Anesthesiology patient classification status (ASA) 2-5
Key exclusion criteria (15 listed)
- Pregnancy
- Exclusions due to limitations with respect to accuracy of MIHM:
- Isolated acute cerebral injury and/or traumatic cerebral injury
- Cardiac arrest prior to enrollment
- Patients with pre-existing, dialysis dependent, renal failure upon admission
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 |
|---|---|---|
| Device: FloTrac™ and EV1000™Minimally invasive hemodynamic monitoring utilizing the FloTrac sensor and EV1000 platform to continuously assess cardiovascular parameters for clinical management. | Device | FloTrac™ and EV1000™ peri-operatively, FloTrac™ and EV1000™ pre and post-operatively |
| Volume ChallengeProtocol-directed fluid administration for optimization of stroke volume variation and cardiac performance. Volume challenge options included crystalloids (normal saline, hypertonic saline, lactated Ringer's), blood products, and albumin | Other | FloTrac™ and EV1000™ peri-operatively |
| Vasopressor TherapyProtocol-directed vasopressor administration based on hemodynamic monitoring data. Agents included norepinephrine, phenylephrine, epinephrine, dopamine, and vasopressin. | Drug | FloTrac™ and EV1000™ peri-operatively |
| Inotropic TherapyProtocol-directed inotropic support based on hemodynamic monitoring data. Agents included dobutamine and dopamine. | Drug | FloTrac™ and EV1000™ peri-operatively |
Primary outcome
Complications
Time frame: Post-operative complications during patient hospital stay up to 6 months
The aim of this study is to determine if the incidence of post-operative complications will decreased with the implementation of intra-operative, minimally invasive hemodynamic monitoring via FloTrac™ and EV1000™ in trauma patients.
7 secondary outcomes
Impact of Intervention on ICU/Hospital mortality rate
Time frame: During patient hospital stay up to 6 months
SOFA scores
Time frame: Within 24 hours pre and post-surgery
Changes in pre and post-operative lactic acid and base deficit
Time frame: Within 24 hours pre and post-surgery
Changes in pre and post-operative APACHE II score
Time frame: Within 24 hours pre and post-surgery
ICU Length of Stay
Time frame: Through ICU discharge, an average of 30 days
Duration of Post-operative Vasopressor Requirement
Time frame: From completion of surgery until vasopressor discontinuation or hospital discharge (up to 6 months)
Hospital length of stay
Time frame: During hospitalization up to 6 months
Results and safety
The study was stopped early (reason given: Lack of research personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Results publication: PubMed 12727572Husain 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.
- Results publication: PubMed 8411283Abramson 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.
- Results publication: PubMed 12904861Cerovic 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.
- Results publication: PubMed 19533847Arnold 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.
- Results publication: PubMed 15286537Nguyen 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.
- Results publication: PubMed 19359912Callaway 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.
- Results publication: PubMed 15920409Dunne 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.
- Results publication: PubMed 22695417Ouellet 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.
- Results publication: PubMed 9308617Ziegler 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.
- Results publication: PubMed 11529214Landry DW, Oliver JA. The pathogenesis of vasodilatory shock. N Engl J Med. 2001 Aug 23;345(8):588-95. doi: 10.1056/NEJMra002709. No abstract available.
- Results publication: PubMed 17099041Otero 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.
- Results publication: PubMed 22735299Monnet 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.
- SOFA CalculatorLink provided by the sponsor.
- APACHE II CalculatorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Audis Bethea, PharmD, BCPS principal investigator
CAMC Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: FloTrac™ and EV1000™, Volume Challenge and Vasopressor Therapy in people with Critical Illness and Trauma, run by CAMC Health System 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 12 inclusion and 15 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: stopped early, as of the sponsor's last update on 9 Sep 2026. 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?
The study was stopped early (reason given: Lack of research personnel). Results are not available in the source record.
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?
Complications (time frame: Post-operative complications during patient hospital stay up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742974, which also lists 34 linked publications.
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 9 Sep 2026.