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

Guangzhou Red Cross Hospital

Status: Completed

Conditions: Hemodynamics

Treatments: Procedure: Goal-directed hemodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05221788

2020-079-02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

GDHT(goal-directed hemodynamic therapy)

Experimental group

Description:

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.

Treatment:

Procedure: Goal-directed hemodynamic therapy

control

No Intervention group

Description:

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.