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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamics
• Intervention / Treatment: Procedure: Goal-directed hemodynamic therapy

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510220
      • Guangzhou Redcross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GDHT(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.	Procedure: 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 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.
No Intervention: control; 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?

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

Collaborators and Investigators

• Sponsor: Guangzhou Red Cross Hospital
• Investigators: Study Director: Yang Cao, Guangzhou Redcross Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2020-079-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No