Back to resultsEffect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns
Primary Purpose
Hemodynamics
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Goal-directed hemodynamic therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Hemodynamics
Eligibility Criteria
Inclusion Criteria:
- the age is between 18 and 65 years old;
- the burn area ≥ 50% total burn surface area (TBSA) or the third degree wound area ≥ 20% TBSA;
- 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:
- Severe cardiac or pulmonary disease prior to the burn injury, combined with severe internal organ damage.
- Patients or family members refusing informed consent for this study.
Sites / Locations
- Guangzhou RedCross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
GDHT(goal-directed hemodynamic therapy)
control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
Incidence of pulmonary complications
Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index <300)
Incidence of neurological complications
Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium)
Incidence of acute kidney injury
defined by acute kidney injury criteria.
postoperative pain conditions
postoperative pain
Secondary Outcome Measures
Blood lacate
an indicator related to microcirculation perfusion
Blood lacate
an indicator related to microcirculation perfusion
Blood lacate
an indicator related to microcirculation perfusion
Blood lactate
an indicator related to microcirculation perfusion
Blood lactate
an indicator related to microcirculation perfusion
Blood lactate
an indicator related to microcirculation perfusion
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
Full Information
NCT ID
NCT05221788
First Posted
January 10, 2022
Last Updated
January 23, 2022
Sponsor
Guangzhou Red Cross Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05221788
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Red Cross Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GDHT(goal-directed hemodynamic therapy)
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Goal-directed hemodynamic therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of cardiac complications
Description
Incidence of cardiac complications within 7 days of surgery (myocardial infarction (electrocardiogram (ECG) and/or troponin T serum concentration; new-onset atrial fibrillation)
Time Frame
within 7 days postoperatively
Title
Incidence of pulmonary complications
Description
Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index <300)
Time Frame
within 7 days postoperatively
Title
Incidence of neurological complications
Description
Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium)
Time Frame
within 7 days postoperatively
Title
Incidence of acute kidney injury
Description
defined by acute kidney injury criteria.
Time Frame
within 7 days postoperatively
Title
postoperative pain conditions
Description
postoperative pain
Time Frame
within 7 days postoperatively
Secondary Outcome Measure Information:
Title
Blood lacate
Description
an indicator related to microcirculation perfusion
Time Frame
before operation (T1)
Title
Blood lacate
Description
an indicator related to microcirculation perfusion
Time Frame
1 hour into the operation (T2)
Title
Blood lacate
Description
an indicator related to microcirculation perfusion
Time Frame
2 hours into the operation (T3)
Title
Blood lactate
Description
an indicator related to microcirculation perfusion
Time Frame
the end of operation (T4)
Title
Blood lactate
Description
an indicator related to microcirculation perfusion
Time Frame
24 hours after operation (T5)
Title
Blood lactate
Description
an indicator related to microcirculation perfusion
Time Frame
7 days after operation
Title
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Description
an indicator related to microcirculation perfusion
Time Frame
before operation (T1)
Title
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Description
an indicator related to microcirculation perfusion
Time Frame
1 hour into the operation (T2)
Title
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Description
an indicator related to microcirculation perfusion
Time Frame
2 hours into the operation (T3)
Title
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Description
an indicator related to microcirculation perfusion
Time Frame
the end of operation (T4)
Title
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Description
an indicator related to microcirculation perfusion
Time Frame
24 hours after operation (T5)
Title
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Description
an indicator related to microcirculation perfusion
Time Frame
7 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the age is between 18 and 65 years old;
the burn area ≥ 50% total burn surface area (TBSA) or the third degree wound area ≥ 20% TBSA;
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:
Severe cardiac or pulmonary disease prior to the burn injury, combined with severe internal organ damage.
Patients or family members refusing informed consent for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Cao
Organizational Affiliation
Guangzhou RedCross Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Guangzhou RedCross Hospital
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510220
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns
We'll reach out to this number within 24 hrs