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Clinical Trials/NCT02742974
NCT02742974TerminatedNot Applicable

Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)

CAMC Health System3 sites in 1 country48 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
48
Locations
3
Primary Endpoint
Complications

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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
  • 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

Exclusion Criteria

  • 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
  • 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

Arms & Interventions

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.

Intervention: Device: FloTrac™ and EV1000™ (Device)

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

Intervention: Device: FloTrac™ and EV1000™ (Device)

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

Intervention: Volume Challenge (Other)

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

Intervention: Vasopressor Therapy (Drug)

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

Intervention: Inotropic Therapy (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • SOFA scores(Within 24 hours pre and post-surgery)
  • Changes in pre and post-operative lactic acid and base deficit(Within 24 hours pre and post-surgery)
  • Changes in pre and post-operative APACHE II score(Within 24 hours pre and post-surgery)
  • Lactic acid and Base deficit changes(Within 24 hours pre and post-surgery)
  • APACHE II(Within 24 hours pre and post-surgery)
  • Impact of Intervention(During patient hospital stay up to 6 months)
  • Impact of Intervention on ICU/Hospital mortality rate(During patient hospital stay up to 6 months)
  • ICU Length of Stay(Through ICU discharge, an average of 30 days)
  • Duration of Post-operative Vasopressor Requirement(From completion of surgery until vasopressor discontinuation or hospital discharge (up to 6 months))
  • Hospital length of stay(During hospitalization up to 6 months)

Investigators

Sponsor
CAMC Health System
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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