An interventional study of BIA-guided fluid resuscitation protocol and Traditional fluid resuscitation protocol in Damage Control, Trauma Abdomen and Acute Compartment Syndrome, sponsored by Nanjing PLA General Hospital. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by Nanjing PLA General Hospital · Not applicable, Interventional, and Treatment
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.
60 studies on the registry are indexed under Abdominal Injuries; 19 are open to participants now.
This study's enrollment of 140 is above the median of 125 across 30 interventional studies indexed under Abdominal Injuries.
Browse Abdominal Injuries studies →Nanjing PLA General Hospital is the lead sponsor of 17 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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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
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
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 strategy determined by treating clinicians according to usual clinical parameters.
Rate of 30-day primary fascial closure
Rate of 100% direct approximation of abdominal fascial edges
Time frame: 30 days
Time to fascial closure
Time to 100% direct approximation of abdominal fascial edges
Time frame: 30 days
Postoperative 7-day fluid volume
Statistics of postoperative 7-day fluid volume Postoperative 7-day fluid fluid use during resuscitation
Time frame: 7 days
Postoperative 30-day mortality
All cause mortality within 30 days
Time frame: 30 days
Postoperative 30-day adverse effects
All cause adverse effects within 30 days
Time frame: 30 days
No study locations are listed for this record.
Ran from Jan 2013 to primary completion in Dec 2017, 59 months.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Nanjing PLA General Hospital