BIA Guided-fluid Management in Postinjury Open Abdomen

Study Overview
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Brief Summary
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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.

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

Conditions
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Damage Control, Trauma Abdomen, Acute Compartment Syndrome

Intervention / Treatment
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* Other: BIA-guided fluid resuscitation protocol
* Other: Traditional fluid resuscitation protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIA-directed fluid resuscitation<br>After the achievement of CVP, MAP and ScvO2 goals, if hyperhydration (HL > 74.3%) was found, then the following fluid management was applied with each passing 6h. If HL was above 87% (severe level), fluid infusion was restricted, a furosemide drip was used, and CRRT was initiated with an ultrafiltration rate when patients were failure or inadequate response to above diuretic therapy that gave a net negative fluid balance of at least 1500 ml during the next 6h. If HL was 81%-87% (moderate level), above methods were used to trigger a net negative fluid balance (about 1000 ml) for the next 6h. Similarly, If HL was 74.3%-81% (mild level), a net negative fluid balance of about 500 ml would be achieved during the next 6h of ICU hospitalization. If HL was blow 71%, a state of dehydration, CVP, MAP, and ScvO2 was maintained as above during ICU resuscitation. | Other: BIA-guided fluid resuscitation protocol<br>* 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.<br>|
| Active Comparator: Traditional fluid resuscitation<br>A timely restricted intravenous fluid regimen or dehydration therapy was implemented by two senior clinicians according to cumulative fluid balance recording and hemodynamic condition such as heart rate, blood pressure, central venous pressure, mean arterial pressure, urine output and body weight change. | Other: Traditional fluid resuscitation protocol<br>* Traditional fluid resuscitation strategy determined by treating clinicians according to usual clinical parameters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of 30-day primary fascial closure | Rate of 100% direct approximation of abdominal fascial edges | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, Open abdomen, Fluid resuscitation, Fascial closure, Bioelectrical impedance analysis