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

Hemodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221788
• Other study ID #: 2020-079-02
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: Guangzhou Red Cross Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamics
• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
China	Guangzhou RedCross Hospital	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Red Cross Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of pulmonary complications	Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index <300)	within 7 days postoperatively
Primary	Incidence of neurological complications	Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium)	within 7 days postoperatively
Primary	Incidence of acute kidney injury	defined by acute kidney injury criteria.	within 7 days postoperatively
Primary	postoperative pain conditions	postoperative pain	within 7 days postoperatively
Secondary	Blood lacate	an indicator related to microcirculation perfusion	before operation (T1)
Secondary	Blood lacate	an indicator related to microcirculation perfusion	1 hour into the operation (T2)
Secondary	Blood lacate	an indicator related to microcirculation perfusion	2 hours into the operation (T3)
Secondary	Blood lactate	an indicator related to microcirculation perfusion	the end of operation (T4)
Secondary	Blood lactate	an indicator related to microcirculation perfusion	24 hours after operation (T5)
Secondary	Blood lactate	an indicator related to microcirculation perfusion	7 days after operation
Secondary	The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)	an indicator related to microcirculation perfusion	before operation (T1)
Secondary	The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)	an indicator related to microcirculation perfusion	1 hour into the operation (T2)
Secondary	The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)	an indicator related to microcirculation perfusion	2 hours into the operation (T3)
Secondary	The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)	an indicator related to microcirculation perfusion	the end of operation (T4)
Secondary	The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)	an indicator related to microcirculation perfusion	24 hours after operation (T5)
Secondary	The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)	an indicator related to microcirculation perfusion	7 days after operation