Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)

Status unconfirmed · Not applicable

Conditions studied: Critical Illness, Trauma

In brief

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.

Key facts

Study ID

NCT02742974

Run by

CAMC Health System

People needed

196

Starts

2015-12-01

Expected to finish

2019-12-01

Last updated by the study team

2016-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Charleston Area Medical Center, General Hospital — Charleston, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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