BIA Guided-fluid Management in Postinjury Open Abdomen

NCT ID: NCT03466684

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2018-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BIA-directed fluid resuscitation

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.

Group Type: EXPERIMENTAL

BIA-guided fluid resuscitation protocol

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Traditional fluid resuscitation protocol

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Traditional fluid resuscitation protocol

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gao Tao

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2012NLY096

Identifier Type: -

Identifier Source: org_study_id