Acute Compartment Syndrome, Damage Control, Trauma Abdomen
Conditions
Keywords
Trauma, Open abdomen, Fluid resuscitation, Fascial closure, Bioelectrical impedance analysis
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.
Interventions
OTHERBIA-guided fluid resuscitation protocol
In both groups, a multi-frequency BIA with eight tactile electrodes (Inbody S10 Biospace, Biospace Co. Ltd., Seoul, Korea) was used to assess body fluid status every 6h within the first 72h after admission to the ICU and daily for a period of 4 days. BIA recording was not adjusted by clinicians in fluid restrict, pharmacological and mechanical means of therapy. In contrast, in group BIA, fluid resuscitation protocol with adjustment determined according to HL measured by BIA.
OTHERTraditional fluid resuscitation protocol
Traditional fluid resuscitation strategy determined by treating clinicians according to usual clinical parameters.
Sponsors
Nanjing PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of 30-day primary fascial closure | 30 days | Rate of 100% direct approximation of abdominal fascial edges |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed