NCT04761237

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

January 19, 2021

Last Update Submit

February 17, 2021

Conditions

Keywords

central venous-arterial carbon dioxide differenceliquid resuscitationtissue perfusion and oxygenation

Outcome Measures

Primary Outcomes (2)

  • 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

  • Lactic acid value

    Lactic acid level in arterial blood

    From start anesthesia until end of anesthesia, up to a maximum of 6 hours

Study Arms (2)

Group 1

EXPERIMENTAL

(H-P) : Pcv-aCO2≥6mmHg between T base and T 0h.;

Drug: Goal-directed fluid therapy (GDET)

Group 2

EXPERIMENTAL

(L-P) : Pcv-aco2\< 6mmHg at T base and≥6mmHg at T 0h

Drug: Goal-directed fluid therapy (GDET)

Interventions

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.

Group 1Group 2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASAI-II
  • New York Heart Association classification of cardiac function I-II
  • Estimated time of operation\<3h
  • The circulatory system of patients is stable after thrapy:CVP8~12 mmHg;MAP≥65 mmHg;urine volume\>0.5m1/kg/ h;ScvO2:≥70%。

You may not qualify if:

  • Anesthetic drug allergy or contraindication
  • Patients with cardiopulmonary system disease、cardiopulmonary function abnormality、severe inhalation injuryand severe visceral injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are prevented from having knowledge of the interventions assigned to individual participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

January 19, 2021

First Posted

February 18, 2021

Study Start

January 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

February 18, 2021

Record last verified: 2021-02