Clinical trial NCT05221788: Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns
Official title: Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns: a Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamics
Lead sponsor: Guangzhou Red Cross Hospital
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Incidence of cardiac complications
timeFrame: within 7 days postoperatively
measure: Incidence of pulmonary complications
timeFrame: within 7 days postoperatively
measure: Incidence of neurological complications
timeFrame: within 7 days postoperatively
measure: Incidence of acute kidney injury
timeFrame: within 7 days postoperatively
measure: postoperative pain conditions
timeFrame: within 7 days postoperatively
Secondary outcomes:
measure: Blood lacate
timeFrame: before operation (T1)
measure: Blood lacate
timeFrame: 1 hour into the operation (T2)
measure: Blood lacate
timeFrame: 2 hours into the operation (T3)
measure: Blood lactate
timeFrame: the end of operation (T4)
measure: Blood lactate
timeFrame: 24 hours after operation (T5)
measure: Blood lactate
timeFrame: 7 days after operation
measure: The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
timeFrame: before operation (T1)
measure: The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
timeFrame: 1 hour into the operation (T2)
measure: The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
timeFrame: 2 hours into the operation (T3)
measure: The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
timeFrame: the end of operation (T4)
measure: The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
timeFrame: 24 hours after operation (T5)
measure: The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
timeFrame: 7 days after operation
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Guangzhou RedCross Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou RedCross Hospital
name: Yang Cao
role: STUDY_DIRECTOR
References: