Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns: a Single-center Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemodynamics
- Sponsor
- Guangzhou Red Cross Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of pulmonary complications
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
Liang Bing
associate chief physician
Guangzhou Red Cross Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Incidence of pulmonary complications
Time Frame: within 7 days postoperatively
Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index \<300)
Incidence of cardiac complications
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)
postoperative pain conditions
Time Frame: within 7 days postoperatively
postoperative pain
Incidence of neurological complications
Time Frame: within 7 days postoperatively
Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium)
Incidence of acute kidney injury
Time Frame: within 7 days postoperatively
defined by acute kidney injury criteria.
Secondary Outcomes
- Blood lactate(7 days after operation)
- Blood lacate(2 hours into the operation (T3))
- The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)(7 days after operation)