Back to resultsBIA Guided-fluid Management in Postinjury Open Abdomen (BGFM)
Primary Purpose
Damage Control, Trauma Abdomen, Acute Compartment Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BIA-guided fluid resuscitation protocol
Traditional fluid resuscitation protocol
Sponsored by
About this trial
This is an interventional treatment trial for Damage Control focused on measuring Trauma, Open abdomen, Fluid resuscitation, Fascial closure, Bioelectrical impedance analysis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BIA-directed fluid resuscitation
Traditional fluid resuscitation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Rate of 30-day primary fascial closure
Rate of 100% direct approximation of abdominal fascial edges
Secondary Outcome Measures
Time to fascial closure
Time to 100% direct approximation of abdominal fascial edges
Postoperative 7-day fluid volume
Statistics of postoperative 7-day fluid volume Postoperative 7-day fluid fluid use during resuscitation
Postoperative 30-day mortality
All cause mortality within 30 days
Postoperative 30-day adverse effects
All cause adverse effects within 30 days
Full Information
NCT ID
NCT03466684
First Posted
March 9, 2018
Last Updated
August 29, 2018
Sponsor
Nanjing PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03466684
Brief Title
BIA Guided-fluid Management in Postinjury Open Abdomen
Acronym
BGFM
Official Title
Bioelectrical Impedance Analysis Guided-Fluid Management Promotes Primary Fascial Closure of Postinjury Open Abdomen
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Damage Control, Trauma Abdomen, Acute Compartment Syndrome
Keywords
Trauma, Open abdomen, Fluid resuscitation, Fascial closure, Bioelectrical impedance analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIA-directed fluid resuscitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional fluid resuscitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
BIA-guided fluid resuscitation protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional fluid resuscitation protocol
Intervention Description
Traditional fluid resuscitation strategy determined by treating clinicians according to usual clinical parameters.
Primary Outcome Measure Information:
Title
Rate of 30-day primary fascial closure
Description
Rate of 100% direct approximation of abdominal fascial edges
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time to fascial closure
Description
Time to 100% direct approximation of abdominal fascial edges
Time Frame
30 days
Title
Postoperative 7-day fluid volume
Description
Statistics of postoperative 7-day fluid volume Postoperative 7-day fluid fluid use during resuscitation
Time Frame
7 days
Title
Postoperative 30-day mortality
Description
All cause mortality within 30 days
Time Frame
30 days
Title
Postoperative 30-day adverse effects
Description
All cause adverse effects within 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
BIA Guided-fluid Management in Postinjury Open Abdomen
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