BIA Guided-fluid Management in Postinjury Open Abdomen

Acute Compartment Syndrome Clinical Trial

— BGFM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466684
• Other study ID #: 2012NLY096
• Status: Completed
• Phase: N/A
• Start date: January 1, 2013
• Est. completion date: March 31, 2018

Study information

• Verified date: March 2018
• Source: Nanjing PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Injuries
• Acute Compartment Syndrome
• Compartment Syndromes
• Damage Control
• Trauma Abdomen

Intervention

Other:
• BIA-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.
• Traditional fluid resuscitation protocol
Traditional fluid resuscitation strategy determined by treating clinicians according to usual clinical parameters.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of 30-day primary fascial closure	Rate of 100% direct approximation of abdominal fascial edges	30 days
Secondary	Time to fascial closure	Time to 100% direct approximation of abdominal fascial edges	30 days
Secondary	Postoperative 7-day fluid volume	Statistics of postoperative 7-day fluid volume Postoperative 7-day fluid fluid use during resuscitation	7 days
Secondary	Postoperative 30-day mortality	All cause mortality within 30 days	30 days
Secondary	Postoperative 30-day adverse effects	All cause adverse effects within 30 days	30 days