Status:
COMPLETED
BIA Guided-fluid Management in Postinjury Open Abdomen
Lead Sponsor:
Nanjing PLA General Hospital
Conditions:
Damage Control
Trauma Abdomen
Eligibility:
All Genders
18-75 years
Phase:
NA
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)...
Eligibility Criteria
Inclusion
- Adult trauma patients admitted to SICU with OA after emergent abbreviated laparotomy were considered eligible.
Exclusion
- (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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03466684
Start Date
January 1 2013
End Date
March 31 2018
Last Update
August 31 2018
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