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

NCT ID: NCT05221788

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-12-01

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).

Conditions

Hemodynamics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Goal-directed hemodynamic therapy

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Red Cross Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liang Bing

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Cao

Role: STUDY_DIRECTOR

Guangzhou RedCross Hospital

Locations

Guangzhou RedCross Hospital

Guanzhou, Guangdong, China

Countries

China

Other Identifiers

2020-079-02

Identifier Type: -

Identifier Source: org_study_id