BIA Guided-fluid Management in Postinjury Open Abdomen

Nanjing PLA General Hospital140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

140

Conditions

Damage Control Trauma Abdomen Acute Compartment Syndrome

Interventions

BIA-guided fluid resuscitation protocolOTHER

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.

Traditional fluid resuscitation protocolOTHER

Traditional fluid resuscitation strategy determined by treating clinicians according to usual clinical parameters.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Rate of 30-day primary fascial closure

Rate of 100% direct approximation of abdominal fascial edges

Time frame: 30 days

Secondary Outcomes

Time to fascial closure

Time to 100% direct approximation of abdominal fascial edges

Time frame: 30 days

Postoperative 7-day fluid volume

Statistics of postoperative 7-day fluid volume Postoperative 7-day fluid fluid use during resuscitation

Time frame: 7 days

Postoperative 30-day mortality

All cause mortality within 30 days

Time frame: 30 days

Postoperative 30-day adverse effects

All cause adverse effects within 30 days

Time frame: 30 days

Data from ClinicalTrials.gov

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