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Completed

NCT Number: NCT03466684

BIA Guided-fluid Management in Postinjury Open Abdomen

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.

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Key information

Conditions

Damage Control Abdominal Injuries Acute Compartment Syndrome Trauma Abdomen Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIA-guided fluid resuscitation protocol

Other

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 protocol

Other

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

Primary outcomes

  1. Rate of 30-day primary fascial closure

    Time frame: 30 days

    Rate of 100% direct approximation of abdominal fascial edges

Secondary outcomes

  1. Time to fascial closure

    Time frame: 30 days

    Time to 100% direct approximation of abdominal fascial edges

  2. Postoperative 7-day fluid volume

    Time frame: 7 days

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

  3. Postoperative 30-day mortality

    Time frame: 30 days

    All cause mortality within 30 days

  4. Postoperative 30-day adverse effects

    Time frame: 30 days

    All cause adverse effects within 30 days

Sponsors and collaborators

Lead sponsor

Nanjing PLA General Hospital

Other

Registry information

Official study title

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

Acronym: BGFM

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Mar 15, 2018
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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