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Completed

NCT Number: NCT05221788

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou RedCross Hospital

Guanzhou, Guangdong, 510220, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of cardiac complications

    Time frame: within 7 days postoperatively

    Incidence of cardiac complications within 7 days of surgery (myocardial infarction (electrocardiogram (ECG) and/or troponin T serum concentration; new-onset atrial fibrillation)

  2. Incidence of pulmonary complications

    Time frame: within 7 days postoperatively

    Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index <300)

  3. Incidence of neurological complications

    Time frame: within 7 days postoperatively

    Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium)

  4. Incidence of acute kidney injury

    Time frame: within 7 days postoperatively

    defined by acute kidney injury criteria.

  5. postoperative pain conditions

    Time frame: within 7 days postoperatively

    postoperative pain

Secondary outcomes

  1. Blood lacate

    Time frame: before operation (T1)

    an indicator related to microcirculation perfusion

  2. Blood lacate

    Time frame: 1 hour into the operation (T2)

    an indicator related to microcirculation perfusion

  3. Blood lacate

    Time frame: 2 hours into the operation (T3)

    an indicator related to microcirculation perfusion

  4. Blood lactate

    Time frame: the end of operation (T4)

    an indicator related to microcirculation perfusion

  5. Blood lactate

    Time frame: 24 hours after operation (T5)

    an indicator related to microcirculation perfusion

  6. Blood lactate

    Time frame: 7 days after operation

    an indicator related to microcirculation perfusion

  7. The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)

    Time frame: before operation (T1)

    an indicator related to microcirculation perfusion

  8. The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)

    Time frame: 1 hour into the operation (T2)

    an indicator related to microcirculation perfusion

  9. The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)

    Time frame: 2 hours into the operation (T3)

    an indicator related to microcirculation perfusion

  10. The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)

    Time frame: the end of operation (T4)

    an indicator related to microcirculation perfusion

  11. The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)

    Time frame: 24 hours after operation (T5)

    an indicator related to microcirculation perfusion

  12. The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)

    Time frame: 7 days after operation

    an indicator related to microcirculation perfusion

Sponsors and collaborators

Lead sponsor

Guangzhou Red Cross Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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