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

NCT05221788 | Completed

• 1 other identifier: 2020-079-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamics

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• Blood lacate

  before operation (T1)

• Blood lacate

  1 hour into the operation (T2)

• Blood lacate

  2 hours into the operation (T3)

• Blood lactate

  the end of operation (T4)

• Blood lactate

  24 hours after operation (T5)

Study Arms (2)

GDHT(goal-directed hemodynamic therapy)

EXPERIMENTAL

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

control

NO INTERVENTION

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.

Interventions

Goal-directed hemodynamic therapy 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.

GDHT(goal-directed hemodynamic therapy)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Red Cross Hospital: lead

Study Sites (1)

Guangzhou RedCross Hospital

Guanzhou, Guangdong, 510220, China

Location

Study Officials

• Yang Cao

  Guangzhou RedCross Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 3, 2022
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

CN (1)