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

Not Applicable

Completed

• Conditions: Hemodynamics
• Interventions: Procedure: Goal-directed hemodynamic therapy

• Registration Number: NCT05221788
• Lead Sponsor: Guangzhou Red Cross Hospital

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).

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-23
• Last Update Submitted: 2022-01-23
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDHT(goal-directed hemodynamic therapy)	Goal-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 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.

Primary Outcome Measures

Name	Time	Method
Incidence of pulmonary complications	within 7 days postoperatively	Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index \<300)
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)
postoperative pain conditions	within 7 days postoperatively	postoperative pain
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.

Secondary Outcome Measures

Name	Time	Method
Blood lactate	7 days after operation	an indicator related to microcirculation perfusion
Blood lacate	2 hours into the operation (T3)	an indicator related to microcirculation perfusion
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)	7 days after operation	an indicator related to microcirculation perfusion

Trial Locations

Locations (1)

Guangzhou RedCross Hospital; 🇨🇳 Guanzhou, Guangdong, China