BIA Guided-fluid Management in Postinjury Open Abdomen

NCT03466684 | Completed

• 1 other identifier: 2012NLY096
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Damage Control; Trauma Abdomen; Acute Compartment Syndrome

Keywords

Trauma; Open abdomen; Fluid resuscitation; Fascial closure; Bioelectrical impedance analysis

Outcome Measures

Primary Outcomes (1)

• Rate of 30-day primary fascial closure

  Rate of 100% direct approximation of abdominal fascial edges

  30 days

Secondary Outcomes (4)

• Time to fascial closure

  30 days

• Postoperative 7-day fluid volume

  7 days

• Postoperative 30-day mortality

  30 days

• Postoperative 30-day adverse effects

  30 days

Study Arms (2)

BIA-directed fluid resuscitation

EXPERIMENTAL

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

Traditional fluid resuscitation

ACTIVE COMPARATOR

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

Interventions

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.

BIA-directed fluid resuscitation

Traditional fluid resuscitation protocol OTHER

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

Traditional fluid resuscitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult trauma patients admitted to SICU with OA after emergent abbreviated laparotomy were considered eligible.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Nanjing PLA General Hospital: lead

MeSH Terms

Conditions

Abdominal Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 15, 2018
• Study Start: January 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-03