Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns: a Single-center Randomized Controlled Trial

Conditions
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Hemodynamics

Intervention / Treatment
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* Procedure: Goal-directed hemodynamic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the age is between 18 and 65 years old; the burn area ≥ 50% total burn surface area (TBSA) or the third degree wound area ≥ 20% TBSA; patients will undergo the first operation after fluid resuscitation (after the shock period). The types of operation include incision decompression, escharectomy and skin grafting, and so on. Exclusion Criteria: Severe cardiac or pulmonary disease prior to the burn injury, combined with severe internal organ damage. Patients or family members refusing informed consent for this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GDHT(goal-directed hemodynamic therapy)<br>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 stroke volume (SV) increased >10%, 200 ml of electrolyte solution was continued until SV increased <10%. After fluid shock, if SV increases <10% but 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 (HR) more than 20% above baseline), plasma was administered until urine output and/or heart rate returned to normal. Fluid responsiveness and hemodynamic variables were reassessed at least every 15 minutes, and more frequently in cases of hemodynamic instability. | Procedure: Goal-directed hemodynamic therapy<br>* 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.<br>|
| No Intervention: control<br>Continuous infusion of compounded sodium lactate 5-7 ml/kg/h was allowed to receive colloidal solution, norepinephrine and dobutamine at the discretion of the anesthesiologist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiac complications | Incidence of cardiac complications within 7 days of surgery (myocardial infarction (electrocardiogram (ECG) and/or troponin T serum concentration; new-onset atrial fibrillation) | within 7 days postoperatively | 
| Incidence of pulmonary complications | Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index <300) | within 7 days postoperatively | 
| Incidence of neurological complications | Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium) | within 7 days postoperatively | 
| Incidence of acute kidney injury | defined by acute kidney injury criteria. | within 7 days postoperatively | 
| postoperative pain conditions | postoperative pain | within 7 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lacate | an indicator related to microcirculation perfusion | before operation (T1) | 
| Blood lacate | an indicator related to microcirculation perfusion | 1 hour into the operation (T2) | 
| Blood lacate | an indicator related to microcirculation perfusion | 2 hours into the operation (T3) | 
| Blood lactate | an indicator related to microcirculation perfusion | the end of operation (T4) | 
| Blood lactate | an indicator related to microcirculation perfusion | 24 hours after operation (T5) | 
| Blood lactate | an indicator related to microcirculation perfusion | 7 days after operation | 
| The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2) | an indicator related to microcirculation perfusion | before operation (T1) | 
| The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2) | an indicator related to microcirculation perfusion | 1 hour into the operation (T2) | 
| The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2) | an indicator related to microcirculation perfusion | 2 hours into the operation (T3) | 
| The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2) | an indicator related to microcirculation perfusion | the end of operation (T4) | 
| The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2) | an indicator related to microcirculation perfusion | 24 hours after operation (T5) | 
| The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2) | an indicator related to microcirculation perfusion | 7 days after operation |