Hemodynamics
Conditions
Brief summary
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
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).
Interventions
PROCEDUREGoal-directed hemodynamic therapy
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.
Sponsors
Guangzhou Red Cross Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. the age is between 18 and 65 years old; 2. the burn area ≥ 50% total burn surface area (TBSA) or the third degree wound area ≥ 20% TBSA; 3. 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
1. Severe cardiac or pulmonary disease prior to the burn injury, combined with severe internal organ damage. 2. Patients or family members refusing informed consent for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain conditions | within 7 days postoperatively | postoperative pain |
| Incidence of pulmonary complications | within 7 days postoperatively | Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index \<300) |
| Incidence of neurological complications | within 7 days postoperatively | Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium) |
| Incidence of acute kidney injury | within 7 days postoperatively | defined by acute kidney injury criteria. |
| Incidence of cardiac complications | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood lactate | the end of operation (T4) | an indicator related to microcirculation perfusion |
| The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2) | before operation (T1) | an indicator related to microcirculation perfusion |
| Blood lacate | before operation (T1) | an indicator related to microcirculation perfusion |
Countries
China
Outcome results
None listed