Recruiting

Fluid Resuscitation

Sponsor:

CAMC Health System

Code:

NCT02742974

Conditions

Critical Illness

Trauma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FloTrac™ and EV1000™

Study Details

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.

Conditions

Critical Illness

Trauma

Study ID

NCT02742974

Start date

Dec, 2015

Status verified date

Apr, 2016

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

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

Study Design

Enrollment

196 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: 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.

experimental: 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

Interventions

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.

Primary outcome measure

  • Complications [ Time Frame: Post-operative complications during patient hospital stay up to 6 months ]

Central Contacts and Locations

Central contacts

Audis Bethea, PharmD, BCPS

304-388-3653audis.bethea@camc.org

Joy S Hogan, LPNph, CCRC

304-388-9957joy.hogan@camc.org

Locations

Charleston Area Medical Center, General Hospital

Recruiting

Charleston, West Virginia, United States, 25301

Contacts

Audis Bethea, PharmD, BCPS

304-388-6260audis.bethea@camc.org

Principal Investigator:

Audis Bethea, PharmD, BCPS

More Information

Sponsor

CAMC Health System

Last update posted

Apr 19, 2016

Last verified

Apr, 2016

Keywords

  • Trauma
  • Minimally Invasive Hemodynamic Monitoring
  • Perioperative
  • Complications
  • Hemodynamics
  • Operative procedures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAMC Health System on 2016-04-19.