Guangzhou RedCross Hospital
Guanzhou, Guangdong, 510220, China
NCT Number: NCT05221788
To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Guanzhou, Guangdong, 510220, China
Objective: To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.
Methods: Ninety-five patients with extensive burns undergoing early debridement grafting were randomly divided into a standard hemodynamic management group (control group) and a goal-directed hemodynamic therapy group (GDHT group), with the control group guided by conventional parameters and the GDHT group guided by SV based on Vigileo. The primary outcome were incidence of cardiac complications, pulmonary complications, neurological disease, acute kidney injury, and pain within 7 days postoperatively. Secondary outcome included microcirculatory perfusion metrics: Lactate (lac), The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2).
Healthy volunteers accepted: No
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Inclusion criteria
Exclusion criteria
Compounded sodium lactate 3 ml/kg/h was given intravenously as a basal rehydration volume before induction, and 200 ml of electrolyte solution was given after induction. If SV increased >10%, 200 ml of electrolyte solution was continued until SV increased <10%. After fluid shock, if SV increases <10% but mean arterial pressure (MAP) <65 mmHg and/or cardiac index (CI) <2.5l/min/m2 give low-dose norepinephrine continuous pumping and/or dobutamine continuous pumping. If hypotension was accompanied by hypovolemia (defined as urine output <0.5 ml /kg/h and/or heart rate more than 20% above baseline), plasma was administered until urine output and/or HR returned to normal. Fluid responsiveness and hemodynamic variables were reassessed at least every 15 minutes, and more frequently in cases of hemodynamic instability.
Time frame: within 7 days postoperatively
Incidence of cardiac complications within 7 days of surgery (myocardial infarction (electrocardiogram (ECG) and/or troponin T serum concentration; new-onset atrial fibrillation)
Time frame: within 7 days postoperatively
Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index <300)
Time frame: within 7 days postoperatively
Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium)
Time frame: within 7 days postoperatively
defined by acute kidney injury criteria.
Time frame: within 7 days postoperatively
postoperative pain
Time frame: before operation (T1)
an indicator related to microcirculation perfusion
Time frame: 1 hour into the operation (T2)
an indicator related to microcirculation perfusion
Time frame: 2 hours into the operation (T3)
an indicator related to microcirculation perfusion
Time frame: the end of operation (T4)
an indicator related to microcirculation perfusion
Time frame: 24 hours after operation (T5)
an indicator related to microcirculation perfusion
Time frame: 7 days after operation
an indicator related to microcirculation perfusion
Time frame: before operation (T1)
an indicator related to microcirculation perfusion
Time frame: 1 hour into the operation (T2)
an indicator related to microcirculation perfusion
Time frame: 2 hours into the operation (T3)
an indicator related to microcirculation perfusion
Time frame: the end of operation (T4)
an indicator related to microcirculation perfusion
Time frame: 24 hours after operation (T5)
an indicator related to microcirculation perfusion
Time frame: 7 days after operation
an indicator related to microcirculation perfusion
Guangzhou Red Cross Hospital
Other
Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns: a Single-center Randomized Controlled Trial
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