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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04761237
Other study ID # 2015-047-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date December 30, 2019

Study information

Verified date February 2021
Source Guangzhou Red Cross Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide [P (v-a) CO2] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.


Description:

Objective: By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide [P (v-a) CO2] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients. Methods: a prospective observational study was conducted on 145 patients with extensive burns admitted to surgical intensive care unit(SICU)of Guangzhou Red Cross hospital from January 2016 to December 2019. All patients received hemodynamic monitoring and goal-directed fluid therapy, patients with central venous oxygen saturation (ScvO2)< 70% were excluded. Patients were divided into the following groups according to the changing trend of Pcv-aCO2 between T base (before induction) and T 0h (after surgery) : group 1 (H-H) : Pcv-aCO2≥6mmHg between T base and T 0h. Group 2 (L-H) : Pcv-aco2< 6mmHg at T base and≥6mmHg at T 0h; Group 3 (H-L) : Pcv-aCO2≥6mmHg at T base and < 6mmHg at T 0h. Group 4( L-L) : Pcv-aCO2 < 6mmHg between T base and T0h.Postoperative basic physiological indicators such as heart rate(HR), blood pressure, central venous pressure (CVP), cardiac output index (CI), Pcv-aCO2 and lactic acid were recorded at 0 and 18 hours after surgery. Oxygen dynamic indicators such as oxygen delivery index (DO2I), oxygen consumption index (VO2I), oxygen uptake rate (O2ER) and so on were calculated. Pearson correlation analysis was used to evaluate the correlation between Pcv-aCO2 and CI. The change of tissue perfusion and oxygenation with different levels of Pcv-aCO2 after fluid resuscitation were analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: 1. ASAI-II 2. New York Heart Association classification of cardiac function I-II 3. Estimated time of operation<3h 4. The circulatory system of patients is stable after thrapy:CVP8~12 mmHg;MAP=65 mmHg;urine volume>0.5m1/kg/ h;ScvO2:=70%? Exclusion Criteria: 1. Anesthetic drug allergy or contraindication 2. Patients with cardiopulmonary system disease?cardiopulmonary function abnormality?severe inhalation injuryand severe visceral injury.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Goal-directed fluid therapy (GDET)
Compensatory dilatation was performed firstly and 5ml/kg crystal solution was added within 30min before induction of anesthesia.When SVV=13%, infusion of colloidal solution 2ml/kg was performed 15-20 minutes.If the increase of SV was=10% after the liquid impact and the SVV was still=13%, the colloidal solution was used again for 2mL/kg and the infusion was maintained until the SVV < 13%.The infusion was stopped when the SVV < 10%.If the increase of SV was less than 10% or CI < 2.0L/min/m2 after infusion, dobutamine was given intravenously to observe the change of SV. If the increase of SV was greater than 10%, dobutamine could be maintained and the above fluid regimen continued.If the increase of SV was less than 10% and MAP=65mmHg, the infusion of liquid was stopped and replaced with 4ml/kg/h infusion for maintenance.If the increase of SV was less than 10% and MAP was less than 65mmHg, the infusion was suspended.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Liang Bing

Outcome

Type Measure Description Time frame Safety issue
Primary Central venous oxygen saturation Central venous oxygen saturation in venous blood From start anesthesia until end of anesthesia, up to a maximum of 6 hours
Primary Lactic acid value Lactic acid level in arterial blood From start anesthesia until end of anesthesia, up to a maximum of 6 hours
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