Bioelectrical Impedance Analysis Guided-Fluid Management Promotes Primary Fascial Closure of Postinjury Open Abdomen

Nanjing PLA General Hospital0 sites140 target enrollmentJanuary 1, 2013

ConditionsDamage Control Trauma Abdomen Acute Compartment Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Damage Control
Sponsor: Nanjing PLA General Hospital
Enrollment: 140
Primary Endpoint: Rate of 30-day primary fascial closure
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Fluid overload (FO), resulting from high volume fluid therapy, is frequent and contributes to excessive visceral edema, delayed fascial closure, and adverse outcomes among postinjury open abdomen (OA) patients. Bioelectrical impedance analysis (BIA) is a promising tool in monitoring fluid status and FO. Thus, we sought to investigate the efficacy of BIA-directed resuscitation among postinjury OA patients.

Registry

clinicaltrials.gov

Start Date

January 1, 2013

End Date

March 31, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nanjing PLA General Hospital

Responsible Party

Principal Investigator

Gao Tao

Clinical Professor

Nanjing PLA General Hospital

Eligibility Criteria

Inclusion Criteria

•Adult trauma patients admitted to SICU with OA after emergent abbreviated laparotomy were considered eligible.

Exclusion Criteria

•(a) age less than 18 years; (b) pregnancy; (c) lactation; (d) limb amputations; (e) mental disorders; (f) diabetes mellitus; (g) pre-existing blood disorders; (h) pre-existing abdominal fistulas; (i) pre-existing terminal illness; (j) liver dysfunction (Child-Pugh class C); (k) New York Heart Association (NYHA) class IV; (l) chronic renal failure requiring dialysis; (m) therapy with an extra-corporeal membrane oxygenator (ECMO); (n) enrolled in an ongoing, interventional RCT; (o) received prior fluids for resuscitation during their ICU stay; (p) expected to die within 1 hour of ICU admission for devastating injuries; (q) activated opt-out process for BGFM trial.