BIA Guided-fluid Management in Postinjury Open Abdomen

Not Applicable

Completed

• Conditions: Damage Control; Trauma Abdomen; Acute Compartment Syndrome

• Registration Number: NCT03466684
• Lead Sponsor: Nanjing PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2017-12-31
• Status Verified: 2018-03
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-15
• Study Completion: 2018-03-31
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of 30-day primary fascial closure	30 days	Rate of 100% direct approximation of abdominal fascial edges

Secondary Outcome Measures

Name	Time	Method
Time to fascial closure	30 days	Time to 100% direct approximation of abdominal fascial edges
Postoperative 7-day fluid volume	7 days	Statistics of postoperative 7-day fluid volume Postoperative 7-day fluid fluid use during resuscitation
Postoperative 30-day mortality	30 days	All cause mortality within 30 days
Postoperative 30-day adverse effects	30 days	All cause adverse effects within 30 days